MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (s/n (b)(4) was used to resuscitate a patient in cardiac arrest.When the autopulse was powered on, the platform displayed a "system error, out of service, revert to manual cpr" error message.Manual cpr was performed and continued throughout the call.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead.As per the customer, the patient's death was not related to the autopulse system.
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (s/n (b)(4) displayed "system error, out of service, revert to manual cpr" was confirmed during functional testing.Archive data could not be downloaded due to the parameters in backup memory (non-volatile ram) had been corrupted.The platform and diagnostic service pc were able to communicate, and apvision3 software confirmed a system error - 136 (internal parameter corrupted).The root cause of the system error was the defective processor board, likely due to the aging of the device.The autopulse platform was manufactured in january 2008 and is over 14 years old, well beyond its expected service life of 5 years.Visual inspection of the returned autopulse platform was performed at zoll.The platform's top cover, front and bottom enclosures, battery lock, and lcd screen were observed damaged, unrelated to the reported complaint.Based on the photos provided by the zoll service team, one of the head restraint wires on the top cover was broken/cut off.The cut head restraint does not render the autopulse platform non-functional.In addition, one of the handles of the front enclosure had multiple cracks around its screw fitting.The interior of the bottom enclosure was scratched with broken screw bosses.Also, the battery lock was twisted.These observed physical damages appeared to be the characteristics of harsh impacts due to user mishandling.During further inspection, it was noted that the backlight of the lcd was not lighting up, most likely due to the defective processor board.All the damaged and defective parts will be replaced to address the issues.The archive data could not be downloaded as the parameters in backup memory (non-volatile ram) had been corrupted due to the defective processor board.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" displayed upon powering up the device, confirming the reported complaint.Technical investigation revealed that the root cause of the system error was the defective processor board, which was replaced to remedy the fault.Subsequently, the autopulse was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with known good batteries for 30 minutes, and the platform passed the test without any issues.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with serial number (b)(4).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 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.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14941024
• Report Number: 3010617000-2022-00738
• Device Sequence Number: 6230904
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown