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	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lcd screen issue was observed during a visual inspection of the returned autopulse platform.The lcd had defective/missing pixels.To remedy the issue, the defective lcd display was replaced.The autopulse passed the initial functional testing.No problem found during archive data review.As part of routine service during testing, the platform was examined and found unrelated to the reported complaint, damaged front cover and the encoder drive shaft does not rotate smoothly, exhibits binding and resistance the front cover was replaced and the sticky clutch plate was deburred to address the issue.The autopulse platform is a reusable device and was manufactured in may 2007 and is 11 years old, well beyond the expected service life of five years.Therefore, this type of physical damage is characteristic of normal wear and tear for the life of the device.Following the repair, the platform passed all functional testing criteria and met all required specifications.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
As reported, the autopulse platform (sn (b)(4)) screen lcd displayed blank upon powering on.No other functional issue was reported.No patient was involved.

• 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: 8175597
• Report Number: 3010617000-2018-01241
• Device Sequence Number: 11268992
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1