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 Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform stopped compressions was confirmed during functional testing and during archive review.The platform failed the initial functional testing due to user advisory (ua) 02 (compression tracking error) message.Root cause was determined to be a faulty drivetrain motor.Review of the archive data indicated user advisory (ua) 02 (compression tracking error) message was recorded around the reported event date.During visual inspection, head restraint wires were observed damaged, thus confirming the customer complaint.In addition, unrelated to the reported complaint, broken battery lock was noted and encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The top cover, battery lock requires replacement and sticky clutch plate needs deburring to address the issue.The autopulse platform is a reusable device and was manufactured in 2008 and is 10 years old, well beyond the expected service life of five years.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.The returned platform had the last preventive maintenance performed 8 years ago.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform sn (b)(4).
Event or Problem Description
The autopulse platform ((b)(4)) was deployed without issue and used on a patient performing continuous compression for an unspecified amount of time, however, after some time the platform stopped compression.Additionally, the platform's head restraint cable was found damaged.No patient harm or consequence was reported.No additional information was provided.

• 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: 7607228
• Report Number: 3010617000-2018-00645
• Device Sequence Number: 11118445
• 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): 06/15/2018

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: 05/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1