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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.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.

Event Description

The autopulse platform (sn: (b)(4)) was used to resuscitate a (b)(6)-year-old male patient in sudden cardiac arrest.The cardiac arrest was not witnessed, and the cause was unidentified.A bystander cpr was not performed, and the patient was in cardiac arrest for 7-10 minutes prior to the ems arrival.The autopulse performed compressions for approximately 2-3 minutes, and then, the platform stopped compressions and displayed fault code 29 (loss of brake connectivity) error message followed by the prompt, "realign patient." the ems crew realigned the patient on the platform and extended the lifeband to readjust and secure 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 realigned and the lifeband was readjusted, but the issue was not resolved.As per the customer, the issue occurred at least 4 times, and each time, attempts were made to clear the error message and restart the mechanical compressions, but the autopulse never restarted compressions after the platform displayed the first error message.Meanwhile, manual cpr was performed during the troubleshooting steps.En route to hospital, manual cpr continued for another 15 minutes.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead at the hospital.As per the customer, the patient's death was not related to the autopulse system.

Manufacturer Narrative

H4 (device manufacture date) was updated.The reported complaint of the "autopulse platform (sn: (b)(6)) stopped compressions and displayed fault code 29 (loss of brake connectivity) error message, followed by the prompt, 'realign patient'" was confirmed in the archive data and during functional testing.The investigation findings revealed a loss of connectivity on the brake drive circuit board.The root cause was the loose connector of the j1 cable of the drivetrain motor.The j1 cable connector was not fully seated on the brake connector of the power distribution board (pdb).Upon visual inspection, no physical damage was observed.A review of the archive showed the autopulse platform stopped compressions due to fault code 29 (loss of brake connectivity) error message around the customer's reported event date; thus, confirming the customer's reported complaint.Per archive, the last time the autopulse platform was used to perform compressions was on (b)(6)2020, on which date, the platform performed 3 sessions of 30, 150, and 37 compressions before it stopped compressions and displayed the fault code 29 error message.During functional testing, the autopulse platform failed to execute take-up due to the fault code 29 error message; thus, confirming the customer's reported complaint.Further investigation revealed that the brake monitoring circuit detected a loss of connectivity on the brake drive circuit board due to the loose connector of the j1 cable of the drivetrain motor, which was not properly seated on the brake connector of the power distribution board.Following service, 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 brake gap inspection was performed and verified the brake gap was within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10435528
• MDR Text Key: 203823634
• Report Number: 3010617000-2020-00795
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/15/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1