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

Model Number	MODEL 100
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon powering up the returned autopulse platform during preventive maintenance, user advisory (ua) 41 (patient temperature sensor failure) error message was displayed intermittently.Temperature sensor cabling was replaced to avoid re-occurrence of (ua) 41.The returned platform never had the preventive maintenance performed for 2 years.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, encoder drive shaft does not rotate smoothly, exhibits binding and resistance was observed.Clutch plate deburring was performed to address the issue.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.
Event or Problem Description
The autopulse platform ((b)(4)) was returned for preventive maintenance.As part of routine service, the device was tested and during initial power up, displayed user advisory (ua) 41 (patient temperature sensor failure) error message on the user control panel.

• 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: 7470974
• Report Number: 3010617000-2018-00487
• Device Sequence Number: 10795195
• 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): 04/27/2018

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: 03/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1