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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform was returned to zoll on 17 jul 2017 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
It was reported that the autopulse platform (sn (b)(4)) displayed a system error, out of service, revert to manual cpr error message.The issue was observed during routine check, no patient was involved with this event.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(4)) displaying a system error, out of service, revert to manual cpr message was reproduced during functional testing; the root cause was due to a defective processor board.The autopulse platform is a reusable device and was manufactured on 02 jul 2010.It has exceeded its expected service life of 5 years.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the user control panel.It was indicated that the processor board was defective and a replacement was necessitated to remedy the issue.As part of routine service during testing, the platform was further tested including a load characterization check and found that the load cell was defective.This observation is not related to the report of a system error, out of service, revert to manual cpr message.After replacement of the processor board and the load cell, the platform was further tested to full specification and passed without any issue observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).

• 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: 6785763
• Report Number: 3010617000-2017-00627
• Device Sequence Number: 1247065
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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: 8700-0700-11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1