MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint that the autopulse platform displayed "system error, out of service, revert to manual cpr" was confirmed during functional testing.The platform was initialized and the software was reinstalled to remedy the platform and passed all the testing and meets all required specifications.Functional evaluation of the returned autopulse platform was unable to be performed as a system error message was observed upon powering up, therefore confirming the reported complaint.After the platform was initialized and the software was reinstalled by using ap version software , it remedied the system error fault.A review of the platform archive log showed there were user advisory (ua) 18 (max take-up revolutions exceeded) message on (b)(6) 20/16.User advisory (ua)2(compression tracking error) on (b)(6) 2016 , user advisory (ua)45(not at "home" position after power-on/restart) on (b)(6) 2016 unrelated to the reported issue.A visual inspection of the returned autopulse platform was performed and found the screw support on top cover was cracked and the back cover ( large) was damaged.The battery clip was bent and the ir port was broken and 1 screw and 1 rubber part of the screw were missing.The autopulse platform is a reusable device and was manufactured on 12/29/2010.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is not related to the reported complaint.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
It was reported that during a shift check, the auto pulse platform (s/n: (b)(4)) displayed 'system error' message upon powering on.When (b)(4) received the device ,they confirmed system error message.No patient involvement was provided.No other information was provided.

• 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: 6248342
• Report Number: 3010617000-2017-00031
• Device Sequence Number: 11148799
• Product Code: DRM
• UDI-Device Identifier: 00849111065092
• UDI-Public: 00849111065092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2016

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1