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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the platform displaying an error message user advisory (ua) 08 (motor controller fault detected) was confirmed during archive review and initial functional testing.Defective drive train motor was replaced to remedy the fault.Additionally, customer noted user advisory (ua) 17 (max motor on time exceeded during active operation) error were confirmed during archive review.However, this error was cleared by the user.The user advisory (ua) 17 error message alerts the user that the drive motor did not reach the target depth within specification when used on a medium/large size stiff patient and when the battery being used has a low voltage.The platform failed the initial functional testing due to user advisory (ua) 08 error message displayed when the platform was powered on.Visual inspection was performed and found no physical damage to the autopulse platform.Review of the archive data indicated (ua) 08 and (ua) 17 errors occurred on the reported event date, thus confirming customer complaint.After replacing the defective parts, the platform was further tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.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
It was reported that during patient use, the autopulse platform (sn (b)(4)) intermittently displayed error message user advisory (ua) 17 (max motor on time exceeded during active operation).Per reporter, the platform stopped compressions after displaying user advisory (ua) 08 (motor controller fault detected).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: 7898793
• Report Number: 3010617000-2018-00966
• Device Sequence Number: 1434460
• 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): 09/21/2018

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: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1