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	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 07/21/2021, the returned autopulse platform (sn (b)(4)) was serviced for preventive maintenance (pm).During the functional testing, the autopulse platform displayed a "system error, out of service, revert to manual cpr" error message.The root cause of the system error was due to a defective processor board, likely attributed to a defective component.Upon visual inspection, noticed a cracked front enclosure.The observed damage appeared to be the characteristics of user mishandling such as a drop.The front enclosure was replaced to remedy the observed issue.The archive data revealed a system error 139 (unable to hold compression position) message.A defective processor board was replaced to remedy the fault.In addition, the archive showed user advisory (ua) 25 (pause position out of range), user advisory (ua) 26 (decompression position not reached), and fault code 27 (encoder fault) as a result of the defective processor board not controlling the brake correctly.The brake gap inspection was performed and verified the brake gap was within the specification.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with a good known test battery until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During preventive maintenance on (b)(6) 2021, the autopulse platform (sn (b)(4)) failed functional testing due to the system error, out of service, revert to manual cpr error message.No patient involvement.

• 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: 12286291
• Report Number: 3010617000-2021-00725
• Device Sequence Number: 14575468
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1