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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On december 16, 2019, during preventive maintenance, the autopulse platform (sn (b)(4)) stopped compressions during initial functional testing.The root cause was due to the defective drive train motor as a result of normal wear and tear of the autopulse platform.The autopulse platform was manufactured in 2014 and is more than 5 years old, past the expected service life of 5 years.Upon visual inspection, no physical damage was observed.During initial functional testing, the autopulse platform stopped compressions.Noticed that the drive train motor has no power and the lifeband did not compress.The drive train motor was replaced to address the problem.The archive data review showed no other significant discrepancies.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).
Event or Problem Description
On december 16, 2019, during preventive maintenance, the autopulse platform (sn (b)(4)) stopped compressions during initial functional testing.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: 9578668
• Report Number: 3010617000-2020-00072
• Device Sequence Number: 2865997
• Product Code: DRM
• UDI-Device Identifier: 00849111001212
• UDI-Public: 00849111001212
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: 8700-0740-27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1