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 (s/n (b)(4)) was returned to zoll uk for evaluation.Device history record (dhr) was reviewed and no previous related complaints were reported for this autopulse platform (s/n (b)(4)).A visual inspection of the autopulse platform was performed and the load plate cover was observed to be damaged.The damaged load plate cover is unrelated to the reported complaint of the platform.A review of the archive data was performed and no discrepancies were observed.Functional testing was performed on the autopulse platform.The autopulse passed testing and function as intended.In summary, the reported complaint was not confirmed during functional tests.Following service, the power distribution board and the load plate cover were replaced as part of the process.After replacing these parts, 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: 5494000
• Report Number: 3010617000-2016-00162
• Device Sequence Number: 314368
• 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: 06/02/2016
• 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