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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform stopped compressions and displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message was confirmed during archive review and not during initial functional testing.Visual inspection was performed and found no physical damage to the autopulse platform.Review of the archive data indicated user advisory (ua) 17 errors occurred on the reported event date, thus confirming customer complaint.Upon inspection, it was found the cable connected from the processor board to the motor controller board was damaged during the closure of the platform bottom cover.After replacing the defective parts, the platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to the 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
During patient use on an obese patient (130-140 kg), the autopulse platform (sn (b)(4)) stopped after 3-5 compressions and displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) on the user control panel.The crew tried to troubleshoot the platform using another batteries, but was unable to clear the error.The crew reverted to manual cpr for an unknown period of time.No known impact or consequence to patient reported.

• 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: 7981446
• Report Number: 3010617000-2018-01039
• Device Sequence Number: 1380987
• 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): 10/18/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 130