MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Zoll has received four autopulse platform's for investigation.The autopulse platform used during the patient use is unknown.A supplemental report will be filed when the investigation has been completed.Event: multiple injuries.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." 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 event of "multiple injuries" 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.Based on available information, the 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.

Event Description

Patient #2: the crew responded to a (b)(6) years old male patient in cardiac arrest.The patient had a medical history of dementia and parkinson's disease.The patient was discovered by the family member under water in the bathtub.Upon crew arrival, the patient was moved from the bathroom into the living room in full arrest.The patient was apneic, pulseless, with fixed dilated pupils.The king airway was placed and the manual cpr was performed while the crew prepared the autopulse platform.The patient was placed on the autopulse platform and the compressions were performed for 27 minutes with ventilation provided by the king airway without any issues.The intraosseous infusion was performed and medications were delivered.The patient's pulse was checked several times with no change in the patient's status.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead at the scene.Coroner's office reported 3 injury cases.However, coroner's office did not provide details of individual patient and injury.The only statement available said: multiple injuries (hemorrhage to the diaphragm, hemorrhage to the kidney, lacerated spleen, lacerated liver, blood in the abdominal cavity, bilateral rib fractures, bruising to the small bowel and abrasions to the lateral chest) were reported by coroner's office for three different patients and these injuries were not assigned to any particular patient.Per coroner's office, it's difficult to determine whether the patient's outcome was due to the circumstances of the death or the device.Ccr 46858 and ccr 46860 were created for the other two patients.Please see the following related mfr report: mfr 3010617000-2019-00984 for patient # 1.Mfr 3010617000-2019-00980 for patient # 3.

Event Description

Please see the following related mfr report: (b)(6) - mfr 3010617000-2019-00984 for patient # 1, and (b)(6) - mfr 3010617000-2019-00980 for patient # 3.

Manufacturer Narrative

Zoll has received four autopulse platforms with sn (b)(4) for investigation.Out of the four autopulse platforms, three platforms with sn (b)(4) showed no device malfunction during the testing.The autopulse platforms passed the functional testing without any fault or error and worked as intended.The autopulse platform is designed to stop when motor fault is detected to ensure safe and optimum cpr.The autopulse platform with sn (b)(4) failed run-in test due to user advisory (ua) 17 error message, unrelated to the reported patient injuries.The root cause for the ua17 error message was due to the defective drive train motor.The drive train motor was replaced to address the ua17 error.After replacement, the autopulse platform passed the final testing without any fault or error.The connection between the four autopulse platforms and the reported patient injury could not be ruled out.The archive data review of the autopulse platforms didn't show any out of specification operating parameters.So, it is likely that the autopulse platform didn't cause the reported injuries.Manual cpr was performed prior to the use of autopulse platform.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9211550
• MDR Text Key: 163552614
• Report Number: 3010617000-2019-00981
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 86