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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform for investigation.A supplemental report will be filed if the product is returned and investigation has been completed.

Event Description

Per a reporter, the autopulse platform driveshaft slot was unable to lock the lifeband clip.The lifeband clip can be removed without depressing the lifeband retainer.No patient involvement.

Manufacturer Narrative

The customer report of autopulse platform driveshaft slot was unable to lock the lifeband clip was confirmed during functional testing of the returned platform.The issue is attributed to a worn-out lifeband retainer.The autopulse platform is a reusable device and was manufactured in october 2008.It has exceeded its expected service life of 5 years and is over 11 years old.This observation is characteristic of normal wear and tear for the age of the device.There was no preventive maintenance performed for the autopulse platform since 2014.As part of routine service during testing, the platform was examined and found physically damaged top cover and front enclosure as a result of user mishandling such as a drop, unrelated to the reported complaint.The top cover and front enclosure need replacement to address the damage.The autopulse platform failed initial functional testing due to user advisory (ua) 02 (compression tracking error) message, unrelated to the reported complaint.The load cell characterization test revealed that one of the load cells is over-reporting.The defective load cell was likely attributed to mishandling such as a platform drop.Also, unrelated to the reported complaint, during the functional testing, observed worn-out encoder shaft due to normal wear and tear.The defective load cell and the worn-out encoder shaft need to be replaced to address the observed issues.The archive data review showed no significant discrepancies around the reported complaint date.The customer declined the repair of the autopulse platform.Service repair will not be performed and the platform will be scrapped.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9527686
• MDR Text Key: 181961206
• Report Number: 3010617000-2019-01166
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 06/04/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1