MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the platform is returned and investigation has been completed.
Event or Problem Description
The autopulse platform (sn (b)(4)) displayed user advisory (ua) 16 (timeout moving to take-up position) error message.The platform powered off and powered on by itself.The reporter was unable to specify if the issue occurred during shift check or patient use.No consequences or impact to patient.
Additional Manufacturer Narrative
The primary reported complaint of fault code 16 (timeout moving to take-up position) on the autopulse platform (sn (b)(4) was confirmed during functional testing and archive data review.The investigation findings revealed that the root cause of the issue was due to the brake gap being out of specification.The brake gap was readjusted to remedy the fault.The secondary reported complaint of the autopulse powers off and on by itself was not confirmed during functional testing.The autopulse platform is designed to turn itself off after 2 minutes if an error occurred.Upon visual inspection of the platform, a tear on the load cover was observed.This observation is not related to the reported complaint.The probable cause for the observed physical damage could be due to user mishandling.The autopulse platform was manufactured in 13 september 2019.Review of the archive data indicated fault code 16 was observed.Upon service completion, the load plate cover will be replaced and final test will be performed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint for autopulse with serial number (b)(4).
Event or Problem Description
The autopulse platform (sn (b)(4) displayed fault code 16 (timeout moving to take-up position) error message.The platform powered off and powered on by itself.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9821168
• Report Number: 3010617000-2020-00245
• Device Sequence Number: 1367457
• Product Code: DRM
• UDI-Device Identifier: 00849111002516
• UDI-Public: 00849111002516
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 8700-0740-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2019
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1