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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional 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.According to available information, 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.In this case, prior to patient use, the autopulse platform (b)(4) powered off by itself.The autopulse platform was powered back on after the customer replaced it with a new battery but the platform displayed error message.It was unknown if the autopulse platform was really used on patient or not, and it was also unknown the rosc (return of spontaneous circulation) status during the resuscitation.Patient death was reported.The autopulse is 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 or Problem Description
During patient use, the autopulse platform (serial # (b)(4)) powered off after powering it on.The nurse replaced the autopulse li-ion battery on the autopulse platform and during power on, the platform displayed fault code 16 (timeout moving to take-up position) error message.Patient death was reported.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, zoll's medical safety assessment (msa) evaluated the incident, and it was determined that the death was not related to the autopulse device.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial # (b)(6) displayed fault code 16 (timeout moving to take-up position) error message was confirmed during archive data review but not confirmed during functional testing.The root cause of fault code 16 was due to a defective drivetrain motor likely attributed to normal wear and tear.The autopulse platform was manufactured in september 2012 and is 9 years old, well past its service life of 5 years.During visual inspection, the front enclosure was observed cracked, unrelated to the reported complaint.The observed physical damage appeared to the characteristics of harsh impact due to user mishandling.The front enclosure needs to be replaced to address the issues.During archive data review, record shows multiple fault code 16 errors occurred, thus confirming the reported complaint.The autopulse did not achieve the target depth for take-up within the specified time (~5 secs) due to the drive train motor being defective (slipped bushing).The drive train motor needs to be replaced to renedy ua16 error.Also, unrelated to the reported complaint, user advisory ua28 (loss of clutch connectivity) recorded in the archive.The cause of ua18 (loss of clutch connectivity) is undetermined but most likely the error was cleared by the customer.User advisory is the clearable error message and is designed into the platform to alert the operator that the autopulse has detected one of several conditions.The ua28 error indicates the loss of clutch connectivity and the recommended action to take for this type of user advisory is to press restart to clear the ua.The autopulse platform passed the initial functional testing without any fault or error.Zoll is awaiting customer's aprroval for service repair.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
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12156299
• Report Number: 3010617000-2021-00619
• Device Sequence Number: 11726678
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 80