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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive data review.The root cause of the issue was due to the brake gap being out of specification and the gap cannot be readjusted due to platform age.A replacement of the drivetrain motor is required to remedy the problem.Visual inspection was performed and found no physical damage to the autopulse platform.The platform failed the initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed when the platform was powered on.The archive data revealed a system error 139 (unable to hold compression position) message on the reported event date.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 and the pdb (power distribution board) needs to be replaced with the current revision.The sticky clutch plate was deburred and, pdb (power distribution board) was replaced.Following the repair, the platform passed all functional testing criteria and met all required specifications.The autopulse platform is a reusable device and was manufactured in 2009.Therefore, this type of issue is characteristic of normal wear and tear for the life of the device.The device has exceeded its expected service life of 5 years.The returned platform last preventive maintenance was performed 5 years ago.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).
Event or Problem Description
The autopulse platform (sn (b)(4)) displayed a system error, out of service, revert to manual cpr message during patient use.No known patient consequences 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: 7887958
• Report Number: 3010617000-2018-00953
• Device Sequence Number: 16200325
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1