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	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message was confirmed during the archive data review and functional testing.The root cause of the error message was due a defective processor board, likely attributed to normal wear and tear.The autopulse platform was manufacture in march 2013 and is over 7 years old, past its serviceable life of 5 years.During visual inspection of the autopulse platform, no physical damage was observed.The archive data review showed the occurrence of system error 132 (internal watchdog timeout); thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr", error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The defective processor board assembly (pca) needs to be replaced to remedy the fault.Awaiting customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial#: (b)(4)) displayed "system error, out of service, revert to manual cpr." 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: 10799130
• Report Number: 3010617000-2020-01104
• Device Sequence Number: 17083847
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/05/2020

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: 8700-0730-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1