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	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on was confirmed during initial functional test and archive data review.The investigation findings revealed the parameters in backup memory (non-volatile ram) was corrupted.Therefore, the root cause of the error message was due to a defective processor board as a result of a defective component.The reported loud clacking sounds from the autopulse platform was not confirmed during functional testing.During visual inspection, no physical damage was observed on the autopulse platform.During archive review, system error latch 136 (invalid parameters corrupted) was recorded, thus confirming the reported complaint.The parameters in backup memory (non-volatile ram) have been corrupted (checked during power-on self-test) due to a defective processor board).The processor board needs to be replaced to remedy the system error.The initial functional test failed due to returned autopulse platform displayed "system error, out of service, revert to manual cpr" error message during power on.Thus, confirming the reported complaint.Waiting for service repair to be completed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
Upon receipt of the device, customer reported that the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.In addition, the platform makes loud clacking sounds.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: 12387885
• Report Number: 3010617000-2021-00777
• Device Sequence Number: 16439217
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 08/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1