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

Model Number	MODEL 100
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 to zoll that the autopulse platform experienced several problems and stoppages during use.No further information provided and no patient involvement was reported.
Additional Manufacturer Narrative
The autopulse platform in complaint was evaluated on 04/11/2016.A dhr review for s/n (b)(4) found no previous complaints related to this event.During the visual inspection, no physical damage was observed.The archive data was not able to be downloaded for analysis.This was due to the processor circuit board was defective and needed to be replaced.No problems found during functional testing.In summary customer's reported complaint could not be confirmed as archive review was unable to download.The load cell characteristics check passed and the internal visual inspection found no damages.The processor board was replaced to remedy the issue with being unable to download the archive data.Also replaced were the power distribution board and the load plate cover.The device passed final testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 5492525
• Report Number: 3010617000-2016-00161
• Device Sequence Number: 16235444
• 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,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1