| Model Number MODEL 100 |
| Device Problem
Visual Prompts will not Clear (2281)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 04/25/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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The reported complaint of "when the autopulse was powered on, the platform displayed the following prompts: 'initializing' and 'align patient on platform, close lifeband, and then press continue'" was confirmed in the archive data but was not confirmed during the functional testing.No device malfunction was observed during the testing, and the platform functioned as intended.The root cause for the reported complaint was due to inserting a battery with low remaining capacity (rc) into the autopulse platform, attributed to user error.Upon visual inspection, no physical damage was observed on the returned autopulse platform.Based on the archive data review, the autopulse li-ion battery (sn: (b)(4)) with 302 mah remaining capacity (rc) was used on the reported event date, and the battery was not fully charged prior to inserting it into the autopulse platform.Based on the archive, the battery was inserted into the platform on (b)(6) 2020 with rc at 1465 mah, and the customer continued using the battery without re-charging it.On the reported event date ((b)(6) 2020), as soon as the autopulse was powered on, the platform displayed ua01 (low battery warning) error message.Warning 1 - low battery warning message will be triggered when there is less than 5 minutes active operation left before battery is too low to operate.However, the user did not replace the battery and pressed restart to clear the error message.When the autopulse was powered back on, the platform displayed ua02 (compression tracking error).The user pressed restart, and ua02 error message was cleared.The archive shows that the platform was repeatedly re-started several more times, and each time, the device was powered back on with ua07 (discrepancy between load 1 and load 2 too large) error messages.During further investigation, the load cell characterization test confirmed that there was no malfunction on the load cells, and both cell modules were functioning within the specification.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Per the autopulse maintenance guide, ua7 is an indication that the patient out of position or the patient is not properly centered.The autopulse platform passed the initial functional test without any fault or error, and therefore, the reported complaint was not confirmed.Run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries was performed for approximately 12 minutes, and the reported complaint could not be replicated.Following service, the autopulse was subjected to the final 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 brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.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.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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The autopulse platform (sn: (b)(4)) was used in an attempt to resuscitate a (b)(6)-year-old male patient in cardiac arrest.It is unknown if the cardiac arrest was witnessed, and the cause was unidentified.It is unknown what the duration of the patient's cardiac arrest was before the patient received manual cpr, which was performed for 11 minutes prior to ems arrival.As reported by the customer, when the autopulse was powered on, the platform displayed the following prompts: "initializing" and "align patient on platform, close lifeband, and then press continue".The ems crew re-aligned the patient and extended the lifeband to re-adjust it.Then, the green start/continue button was pressed to start chest compressions; however, the platform immediately displayed the same prompts again.The patient was re-aligned and the lifeband was re-adjusted, but the issue was not resolved.As reported, the ems crew attempted to get the autopulse platform to perform compressions several times with no success, and they switched to manual cpr for an unknown amount of time.Once arrived to the emergency department (ed), an alternative device was used to resuscitate the patient.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead in the hospital within 30 minutes of arrival at the ed.As per the customer, it is unknown if the patient's death was related to the autopulse system.
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Manufacturer Narrative
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The reported complaint of "when the autopulse was powered on, the platform displayed the following prompts: 'initializing' and 'align patient on platform, close lifeband, and then press continue'" was confirmed in the archive data but was not confirmed during the functional testing.No malfunction was observed which could have caused or contributed to the patient's death.The autopulse platform functioned appropriately and as intended.The likely root cause relates to a lifeband caught on one side of the roller.This would account for the ua alerts observed on the archive.The platform was refurbished in 2015.Our records indicate that the ap platform has not received any routine preventative maintenance since 2015.Upon visual inspection, no physical damage was observed on the returned autopulse platform.A review of the archive file showed occurrences of one ua1 (low battery warning), one ua2 (compression tracking error), multiple ua7 (discrepancy between load 1 and load 2 too large), and one ua18 (max take-up revolution exceeded) error messages recorded on april 25, 2020.User advisory 1 occurs when there is less than 5 minutes active operation left before battery is too low to operate.This normally is experienced when the battery needs to be charged.In this case, the archive file data showed that the battery was left for ten continuous days in the autopulse platform without recharging.The operator manual specifies daily charging of the batteries.User advisory 2 occurs when the drive shaft rotates but the load sensors do not see the expected increase in load as the lifeband tightens to compress the chest.This normally is experienced when one side of the lifeband is twisted and became jammed in the roller area.In such situation, the autopulse ends up pulling the lifeband belt in on that side, but the patient's chest recoil will not be forceful enough to pull it back out.In this case, the customer observation that the lifeband had twisted on one side, confirms the cause of the ua2.Twisted lifeband is usually an installation error.User advisory 7 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The load sensing mechanism is continuously on during power-on state.Normally the load imbalance is experienced if the patient not oriented on the autopulse platform correctly or the patient has shifted due to compression force without restraints or during transportation.In this case, based on the archive data, the patient was tilted on one side.User advisory 18 occurs when the driveshaft has travelled past the maximum number of revolutions without detecting a patient.This normally is experienced if there is no patient on the autopulse or the patient is too small.No other discrepancies were noted.The li-ion battery (s/n 49789) was the only battery used and it was very low charged at the time of use.Based on the archive file data, the user powered on the platform and the platform displayed ua1-low battery warning followed by ua2.User advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The user powered off/on the platform it displayed ua7 both times.The user powered off the platform.The user performed this step four more times and each time the platform displayed ua7.The user powered off the platform.The user powered on the platform again and it displayed ua18.The user powered off the platform.The user powered on the platform again and it displayed ua7.The user powered off the platform.The user performed this step two more times and each time the platform displayed ua7.The user powered off the platform.The autopulse platform passed functional test without any fault or error.Run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries was performed for approximately 12 minutes.Following service, the autopulse was subjected to the final run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Additional maintenance and inspections were completed to address issues unrelated to the reported complaint to ensure that the autopulse will continue to function properly, including load cell characterization and brake gap inspection.The brake gap inspection verified the brake gap is within the specification.Load cell characterization test verified both cell modules are functioning within the specification.Thus, we recommend that staff be trained on battery management per ifu.The autopulse power system user guide states: "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery".A fully charged li-ion battery left in a zoll autopulse platform for an extended period will eventually discharge below its minimum operating voltage.If you choose, zoll is willing to provide operational training for autopulse platform also.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.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.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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The autopulse platform (sn: (b)(6)) was used in an attempt to resuscitate a 72-year-old male patient in cardiac arrest.It is unknown if the cardiac arrest was witnessed, and the cause was unidentified.It is unknown what the duration of the patient's cardiac arrest was before the patient received manual cpr, which was performed for 11 minutes prior to ems arrival.As reported by the customer, when the autopulse was powered on, the platform displayed the following prompts: "initializing" and "align patient on platform, close lifeband, and then press continue".The ems crew re-aligned the patient and extended the lifeband to re-adjust it.Then, the green start/continue button was pressed to start chest compressions; however, the platform immediately displayed the same prompts again.The patient was re-aligned and the lifeband was re-adjusted, but the issue was not resolved.As reported, the ems crew attempted to get the autopulse platform to perform compressions several times with no success, and they switched to manual cpr for an unknown amount of time.Once arrived at the emergency department (ed), an alternative device was used to resuscitate the patient.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead in the hospital within 30 minutes of arrival at the ed.As per the customer, it is unknown if the patient's death was related to the autopulse system.Please see the following related mfr reports: ccr (b)(4), mfr # 3010617000-2020-00581 for patient 1.Ccr (b)(4), mfr # 3010617000-2020-00582 for patient 2.Ccr (b)(4), mfr # 3010617000-2020-00584 and mfr # 3010617000-2020-00585 for patient 3.
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