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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During patient use, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" message on the user control panel.No further information received.No known impact or patient consequence was reported.

Manufacturer Narrative

The report of the autopulse platform (sn (b)(6)) displaying a system error, out of service, revert to manual cpr message was confirmed during functional testing and archive data review.The root cause was due to defective drive train.Unrelated to the reported complaint, damaged short and long black cover were observed during visual inspection.This types of physical damages observed were likely attributed to mishandling.During archive data review, latch error 139 (unable to hold compression position) was observed on the reported event date, thus confirming the reported complaint.Initial functional testing of the returned autopulse platform could not be performed due to a "system error, out of service, revert to manual cpr" message.An autopulse vision software was used to clear the error message on the autopulse platform.During re-evaluation of the autopulse platform, user advisory - ua17 (max motor on time exceeded during active operation) displayed on the screen panel.The root cause of ua17 was due to a defective drivetrain motor.To remedy ua17, the defective drivetrain motor was replaced.According to zoll service engineer, the system error 139 (unable to hold compression position) and ua17 error messages were related because of same failure mode identified.After completing service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed all functional tests and it is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with sn (b)(6).(b)(4) was reported on 16 august 2018 and the drive train motor was replaced.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9527665
• MDR Text Key: 179289475
• Report Number: 3010617000-2019-01201
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1