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 Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/18/2016
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 autopulse platform (s/n (b)(4)) stopped working unexpectedly.No information was provided if a patient was involved with this event.No additional information was provided.
Additional Manufacturer Narrative
The autopulse platform in complaint was evaluated on (b)(4) 2016.A historical review of complaints does not identify a trend and it has been added to trend analysis.During the visual inspection, no physical damage was observed.The archive log could not be downloaded for analysis due to a faulty processor circuit board.The processor circuit board was replaced to remedy the issue with not being able to download the archive data.A functional testing was performed and the autopulse platform passed testing.In summary, the reported complaint was not confirmed during functional tests.Follow ing service, the power distribution board was replaced as part of the process.An annual service on the platform was performed.The platform was re-evaluated through functional testing and the platform passed all 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: 5493043
• Report Number: 3010617000-2016-00160
• Device Sequence Number: 314375
• Product Code: DRM
• UDI-Device Identifier: 00849111001199
• UDI-Public: 00849111001199
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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: 8700-0740-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1