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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

The zoll autopulse platform was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During shift check, the autopulse platform displayed user advisory (ua) 16 (timeout moving to take-up position) error message.No patient involvement.

Manufacturer Narrative

The reported complaint of user advisory - "(ua)16" (timeout moving to take-up position) error message on the autopulse platform (sn (b)(6) was confirmed during the initial functional test and archive data review.The investigation findings revealed the autopulse platform did not achieve the target depth for take-up within the specified time due to a slipped bushing on the drive train motor as a result of wear and tear.The defective drivetrain motor was replaced to address the user advisory (ua) 16 error.The returned autopulse platform was manufactured in february 2014 and it is 6 years old, well past beyond its expected service life of 5 years.The platform failed the initial functional testing due to error message user advisory (ua) 16 displayed when the platform was powered on.Review of the archive data indicated user advisory (ua) 16 errors occurred on the reported event date.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, a load plate cover was observed damaged.This type of physical damage on the platform is likely attributed to user mishandling.To remedy the damage the top cover was replaced.Following the repair, the autopulse platform 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.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of reported complaints for autopulse platform sn (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: 9528283
• MDR Text Key: 179424251
• Report Number: 3010617000-2019-01192
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• 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: 02/04/2020

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1