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	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon powering up the returned autopulse platform during preventive maintenance, intermittent lcd backlight was observed on the platform screen.The root cause was due to the defective processor board.The autopulse passed the initial functional test without any fault or error.As part of routine service during testing, the platform was examined and both patient head restraint wires were noted to be broken or cut and encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The top cover was replaced and sticky clutch plate was deburred to address the issue.The autopulse platform is a reusable device and was manufactured in 2011 and has exceeded its expected service life of 5 years.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.
Event or Problem Description
During a preventive maintenance for autopulse platform (sn: (b)(4)), the lcd was observed to be flickering.

• 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: 7505209
• Report Number: 3010617000-2018-00547
• Device Sequence Number: 18880466
• Product Code: DRM
• UDI-Device Identifier: 00849111000291
• UDI-Public: 00849111000291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/10/2018

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1