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

Model Number MODEL 100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reported issue of the autopulse platform (sn (b)(4)) was confirmed during functional testing.The root cause was due to the burr in the clutch.The clutch plate was deburred to remedy the issue.Upon visual inspection, observed a damaged power switch, unrelated to the reported event.The power button and the power switch were replaced to remedy the issue.Unable to perform initial functional testing due to the stuck lifeband.The archive data review showed occurrence of ua17 (motor on for too long during active operation) on the customer reported event date, unrelated to the reported event.The brake gap was adjusted to remedy the issue.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

As reported, the user wouldn't able to release the lifeband from the autopulse platform (sn (b)(4)).No additional information was provided.No consequences or impact to patient information was available.

Manufacturer Narrative

The reported issue of "the user wouldn't able to release the lifeband from the autopulse platform (sn (b)(4) was confirmed during functional testing and archive data review.The root cause was due to the burr in the clutch and the brake gap was out of specification.The clutch plate was deburred and the brake gap was adjusted to remedy the issue.Upon visual inspection, observed a damaged power switch, unrelated to the reported problem.The power button and the power switch was replaced to remedy the issue.Unable to perform initial functional testing due to stuck lifeband.The lifeband was stuck inside the driveshaft channel due to shaft being unable to rotate.The archive data review showed occurrence of user advisory (ua) 17 (max motor on time exceeded during active operation) on the customer reported event date.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8448298
• MDR Text Key: 139724242
• Report Number: 3010617000-2019-00216
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 03/08/2019
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1