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	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the autopulse platform (sn (b)(4)) revealed damaged wire restraint loop.The autopulse platform is a reusable device and was manufactured on 23 nov 2007 and has exceeded its service life of 5 years old.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.As part of routine service during testing, the platform was evaluated.Upon initial functional testing, the platform displayed a system error, out of service, revert to manual cpr message.The archive data was reviewed and contained a system error 136 (internal parameter corrupted) message.The system error message was due to a defective processor board.Upon customer approval the processor board will be replaced and the device will be further tested to full specification.
Event or Problem Description
It was initially reported by the customer that the autopulse platform (sn (b)(4)) wire restraint loop was damaged.The autopulse platform was returned to zoll for investigation.During initial functional testing, the platform displayed a "system error, out of service, revert to manual cpr" message upon power up.

• 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: 8232655
• Report Number: 3010617000-2019-00019
• Device Sequence Number: 1107011
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1