MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventive maintenance, the autopulse platform (sn (b)(4)) displayed an error message "system error, out of service, revert to manual cpr".The defective processor board was replaced to remedy the fault.The platform failed the initial functional testing due to a system error, (latch error 136 - internal parameter corrupted) was observed upon powering up the device.Visual inspection was performed and found damaged encoder and motor cover.Following the replacement of defective parts, the device was further tested and passed all testing criteria with no issues or faults observed.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in 2006.Therefore, this type of physical damages found during the visual inspection are characteristics of normal wear and tear for the life of the device.The platform has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of reported complaints for autopulse (b)(4).
Event or Problem Description
During preventative maintenance (pm) service on the returned autopulse platform ((b)(4)), 'system error, out of service, revert to manual cpr' error message displayed on the screen during the initial functional test.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8153227
• Report Number: 3010617000-2018-01223
• Device Sequence Number: 252400
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1