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	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the platform is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" message.No patient involvement.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(6)) displaying a system error, out of service, revert to manual cpr message was not confirmed during functional testing and archive data review.The platform performed as intended.No device malfunction.Per archive data, the last time the autopulse platform was used or powered on by customer on (b)(6) 2019 and no system error was recorded.Per customer, the problem occurred date was on (b)(6) 2020 and there was no evidence on the archive data showing that the platform was used on the customer reported event date.Probably, the customer reported on a wrong platform.Unrelated to the reported complaint, cracked top cover and cracked short black cover was observed during visual inspection.Root cause were likely attributed to mishandling such as a drop.During functional testing, no issues were observed.During archive data review, no issues were observed.Awaiting customer's approval for service repair.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9888937
• Report Number: 3010617000-2020-00337
• Device Sequence Number: 2077703
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 05/15/2020

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1