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)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that during a shift check the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 20 (position out of range) error message.To troubleshoot the issue the biomed tried rotating the drive train, however this did not resolve the issue.No patient involved during this event.No additional information was provided.
Additional Manufacturer Narrative
The autopulse platform (s/n: (b)(4)) was returned to zoll and evaluated.Visual inspection was performed and found damage to the long black exterior cover.Upon powering on the device, the user advisory (ua) 20 (position out of range) error message occurred.To resolve the issue, the encoder was replaced.Archive review was checked.Functional testing was performed and no faults were reported.In summary, the customer's reported complaint was confirmed.The autopulse platform is a reusable device and was manufactured in 2011.Therefore, this type of issue found during inspection is characteristic of normal wear for the life of the device.The encoder was replaced.Annual service checks were completed.Additional repair was performed unrelated to the reported complaint to ensure that the autopulse platform is functional without issue.The long and short black covers and battery latch lock were replaced.The platform passed all final testing criteria.

• 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: 5797193
• Report Number: 3010617000-2016-00477
• Device Sequence Number: 16315387
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• 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: foreign,health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

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: 8700-0700-02-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1