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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of user advisory - ua27 (encoder fault) error message on the autopulse platform (sn (b)(4)) was not confirmed during functional test and data archive review.However, ua17 (motor on for too long during active operation) was observed in the platform's archive.No physical damage observed on the ap platform during visual inspection.The autopulse platform is a reusable device and was manufactured in march 2008.The device has been operating for over 10 years and has exceeded its expected serviceable life of 5 years.During archive data review, ua27 was not identified, thus not confirming the reported complaint.However, ua17 was identified on the date the issue occurred.The brake gap was found too wide (out-of-specification).Both the set screws holding the brake hub to the shaft were loose as a result of wear and tear.Per standard service process, the defective dive train motor was replaced to remedy the issue.The autopulse platform passed the initial functional testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).
Event or Problem Description
As reported, during shift check, the autopulse platform (sn (b)(4)) displayed a user advisory - ua27 (encoder fault) error message during power on.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7945410
• Report Number: 3010617000-2018-01009
• Device Sequence Number: 1355843
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1