| Model Number MODEL 100 |
| Device Problem
Use of Device Problem (1670)
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| Patient Problems
Abrasion (1689); Bone Fracture(s) (1870); Injury (2348)
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| Event Date 01/26/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The device associated with this complaint was not returned for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Event: tangential skin irritation on the side of the torso.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Based on available information, the event of "tangential skin irritation on the side of the torso" was not serious since it didn't meet any criteria of seriousness per regulations.Due to the tangential skin irritation location and the time point, the event of "tangential skin irritation on the side of the torso" was possibly related to the autopulse device.In the same time, the patient is obese, and the oversize body with very tight lifeband also can cause skin abrasion.Event: fat embolism in both lung wings.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen, etc.), and common clinical events secondary to those injuries (pneumothorax, etc.) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Both manual and mechanical cprs can cause rib fractures, however the information regarding if manual cpr was performed or not is unknown for this case.Based on available information, the event of "fat embolism in both lung wings" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Event: punctured diaphragm due to broken ribs.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen, etc.), and common clinical events secondary to those injuries (pneumothorax, etc.) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Both manual and mechanical cprs can cause rib fractures, however the information regarding if manual cpr was performed or not is unknown for this case.Based on available information, the event of "punctured diaphragm due to broken ribs" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Event: multiple rib fractures.Rib fractures is expected adverse event for both manual and mechanical cprs.Large randomized clinical trials (circ, linc) showed no difference in the event rate for rib fracture between the manual compression arms and the mechanical compression arms.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Both manual and mechanical cprs can cause rib fractures, however the information regarding if manual cpr was performed or not is unknown for this case.Based on available information, the event of "multiple rib fractures" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Event: punctured lung due to broken ribs.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen, etc.), and common clinical events secondary to those injuries (pneumothorax, etc.) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Both manual and mechanical cprs can cause rib fractures, however the information regarding if manual cpr was performed or not is unknown for this case.Based on available information, the event of "punctured lung due to broken ribs" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Event: death.The patient's death was not related to the autopulse device.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.
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Event Description
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On 02/04/2020, received the customer feedback about the platform stopped compressions after every shock when the platform was synchronized with aed device (x series).The compressions were resumed after the user pressed the start button.On 02/13/2020, received an update from the customer; during the call, the autopulse platform was used on an obese patient.Per reporter, the platform was used with aed device (x series).The autopulse platform was not connected to the aed device.The platform stopped compressions after every shock.The compressions were resumed after the user pressed the start button.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead.Per forensic doctor, the patient was diagnosed with multiple rib fractures, punctured lung due to broken ribs, punctured diaphragm due to broken ribs, tangential skin irritation on the side of the torso.In addition, the patient had fat embolism in both lung wings.Please see the following related mfr report: mfr 3010617000-2020-00225 for autopulse lifeband.
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Manufacturer Narrative
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The reported complaint of "the autopulse platform (sn (b)(6)) stopped compressions was not confirmed during the functional testing.The autopulse platform passed the initial functional testing without any fault or error.No device malfunction was observed during the testing and the autopulse platform worked as intended.Visual inspection was performed and noted no physical damages upon receipt.Unrelated to the reported complaint, the platform was examined and found an encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The sticky clutch plate needs deburring to address the encoder driveshaft issue.The autopulse platform is a reusable device and was manufactured in 2011 and is 9 years old, well beyond the expected service life of 5 years.Therefore, this type of drive shaft issue is the characteristics of normal wear and tear for the age of the device.The archive log file revealed the autopulse platform stopped compression multiple times due to user advisory (ua) 17.Based on the archive review, the li-ion battery sn (b)(4)was used (1235 mah remaining capacity) with the platform.The device was powered on and had 6 sessions (performed 2, 88, 15, 35, 336 and 12 compressions), on a medium/large size patient and then stopped due to user advisory (ua) 17 error, followed by the battery-low warning message.The battery's remaining capacity dropped to 1005 mah.The user pressed restart to clear the error.The autopulse was used again with the same battery and stop compressing multiple times due to user advisory (ua) 17 error.The autopulse did not reach target depth within the specification due to the stiffness of the patient's chest.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.User advisory (ua) 17 error message alerts the user that the drive motor did not reach the target compression depth within specification when used on a medium/large size stiff patient or when the battery being used has a low voltage or the lifeband is twisted.The reason the autopulse platform stops after a few compressions, it is trying to build-up to the 20% compression depth and cannot do it in the specific time frame but did not have enough power to achieve this compression rate within 0.38 seconds.The load cell characterization test was performed and confirmed both cell modules are functioning within the specification.A drive train motor brake gap inspection was performed and verified within the specification.The autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The patient's death was not related to the autopulse device.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.The patient had both untrained bystander manual cpr and autopulse mechanical cprs.Both manual and mechanical cprs can cause adverse events, and untrained bystander manual cpr seems to have more chance to have adverse event.Based on available information, the event of "massive fat embolism in both lung wings, diaphragmatic perforation, lung laceration, and hemopneumothorax" were possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.The event of "tangential skin irritation /hematoma" on the left and bleeding on the right side of the thorax" was not serious since it didn't meet any criteria of seriousness per regulations.Due to the event location and the time point, the event of "tangential skin irritation /hematoma on the left and bleeding on the right side of the thorax" was possibly related to the autopulse device.In the same time, the patient is obese, and the oversize body with very tight lifeband also can cause skin abrasion.Rib fractures is expected adverse event for both manual and mechanical cprs.Large randomized clinical trials (circ, linc) showed no difference in the event rate for rib fracture between the manual compression arms and the mechanical compression arms.Based on available information, the event of "multiple fractures of multiple ribs" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".
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Event Description
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On (b)(6) 2020, received the customer feedback about the platform stopped compressions after every shock when the platform was synchronized with aed device (x series).The compressions were resumed after the user pressed the start button.On (b)(6) 2020, received additional information from the customer; during the call, the autopulse platform was used on a 61 years old obese patient (approximately 95 kg).The patient had a medical history of arterial hypertension and was prescribed an amlodipin.The cardiac arrest was witnessed.The bystander cpr was immediately performed by an untrained person and then by an ems personnel for approximately 20 minutes.Per a reporter, the platform was used with an aed device (x series).The autopulse platform was not connected to the aed device and sync was over cpr stat pads.The platform performed compressions for a total of 50 minutes.During the use, the platform compressions were interrupted several times due to the displaced lifeband because of the shape of the patient's thorax.The issue was noted by the crew members and lifeband placement was adjusted.In addition, the platform stopped compressions multiple times after the synchronized shock performed by the aed device.The compressions were resumed after the user pressed the start button.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead in the hospital.According to the forensic doctor, the cause of death was due to a heart attack.Per forensic doctor, the patient was diagnosed with hemopneumothorax, multiple fractures of multiple ribs, lung laceration, diaphragmatic perforation and tangential skin irritation /hematoma on the left and bleeding on the right side of the thorax.In addition, the patient had massive fat embolism in both lung wings.Please see the following related mfr report: mfr (b)(4) for autopulse lifeband.
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Search Alerts/Recalls
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