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

Model Number	MODEL 100
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform for evaluation.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 an evaluation of the autopulse platform (s/n (b)(4) prior to use the device showed missing pixels in the platform display screen.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 for evaluation.The customer's reported complaint that the platform showed missing pixels in the display screen were confirmed during visual inspection but not during functional testing.The lcd screen was replaced to remedy the issue.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Therefore, the exact root cause could not be determined.The autopulse platform is a reusable device and was manufactured on 12/29/2011.Therefore, this type of damage found is characteristic of normal wear and tear for the life of the device.After replacing the lcd screen, the platform passed all final functional testing criteria.A review of the platform archive was performed and there were no problems found in the internal log.Additionally, visual inspection showed no damages to the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (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: 6045612
• Report Number: 3010617000-2016-00737
• Device Sequence Number: 1420354
• Product Code: DRM
• UDI-Device Identifier: 00849111001250
• UDI-Public: 00849111001250
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

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: Service Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1