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	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on (b)(6) 2018 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (b)(4) displayed an error message " system error, out of service, revert to manual cpr".No patient was involved.
Additional Manufacturer Narrative
The reported event was confirmed during functional testing and archive data review of the autopulse platform (sn (b)(4)); the root cause was due to the communication error from the drive train motor.The autopulse platform is a reusable device and was manufactured on 22-mar-2013 and has exceeded its expected service life of 5 years.The returned platform never had the preventive maintenance performed for 5 years.The archive data was reviewed and contained a system error message.In addition, to the reported complaint, archive noted a user advisory (ua) 08 (motor controller fault detected).Defective drive train motor was replaced to avoid a reoccurrence of (ua) 08 error message.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message.The platform was connected to the autopulse vision software and the error message was able to be cleared.As part of routine service during testing, the platform was examined and found physical damages.The observed physical damages were unrelated to the reported event.Upon replacement, the platform was further tested including the load characterization check and passed the testing.The platform operated with continuous compression on both the normal and large resuscitation fixture without any issues or error messages 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: 7625387
• Report Number: 3010617000-2018-00646
• Device Sequence Number: 1396569
• Product Code: DRM
• UDI-Device Identifier: 00849111000291
• UDI-Public: 00849111000291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/29/2018

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1