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

Model Number	MODEL 100
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The primary report of the autopulse platform (sn (b)(4)) powering off intermittently was not reproduced during functional testing of platform, and could not be confirmed through review of the retrieved archive data.The archive data recorded no session around the reported event date of (b)(6) 2018.The report of the autopulse platform (sn (b)(4)) powering off intermittently on (b)(6) 2018 was not reproduced during functional testing of platform.The secondary report of the platform has a damaged top cover was confirmed upon visual inspection.It is attributed to mishandling.Part of routine testing, the platform was observed with no brake activation upon power on due to the drive train motor brake gap was out of specification.Upon adjustment the platform was tested and passed within specification.This is not related to the reported event.Historical complaints were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).
Event or Problem Description
As reported, the autopulse platform (sn (b)(4)) intermittently powered off during shift check.In addition, the user observed damaged top cover on the platform.No patient involvement.

• 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: 7559167
• Report Number: 3010617000-2018-00591
• Device Sequence Number: 16612284
• Product Code: DRM
• UDI-Device Identifier: 00849111000239
• UDI-Public: 00849111000239
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 8700-0700-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1