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 Patient Involvement (2645)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventive maintenance on january 8, 2020 and during functional testing, the autopulse platform (serial # (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.The root cause of the error message issue was due to brake gap out-of-specification in which is likely attributed to normal wear and tear.The autopulse platform was manufactured in january 2011 and is 9 years old, well beyond the expected serviceable life of 5 years.Brake gap was adjusted to manufacturing specification to remedy error message.Unrelated to the "system error, out of service, revert to manual cpr", a cut patient wire restraint was observed on the autopulse platform during visual inspection.This issue is likely due to user error.The top cover was replaced to remedy the cut wire restraint.Also observed, damaged load plate cover.This physical damage on the autopulse platform is likely attributed to mishandling.The bottom cover was replaced to remedy the damaged plate cover.After service completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.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
During preventive maintenance on january 8, 2020, the returned autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " during functional test.

• 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: 9645155
• Report Number: 3010617000-2020-00111
• Device Sequence Number: 19367935
• Product Code: DRM
• UDI-Device Identifier: 00849111001250
• UDI-Public: 00849111001250
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (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): 01/29/2020

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: 8700-0740-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1