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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying user advisory (ua) 16 (timeout moving to take-up position) error message was confirmed during functional testing and archive review.The platform is a reusable device and was manufactured on 20 jun 2007 and has exceeded its expected service life of 5 years.The platform is almost 11 years old and has not seen regular preventive maintenance.The platform was functionally tested and upon pressing the start/continue button, it displayed a ua 16 error message on the user control panel.The root cause of the ua 16 error message is attributed to a seized brake gap.The ua 16 error message was cleared after the brake gap was unseized.The archive data was reviewed and contained ua 16 error on (b)(6) 2017, which was the last power up of the platform and not on the reported event date of (b)(6) 2018, thus confirming the reported event.As part of routine service during testing, the platform was examined and found a damaged top cover and the sticky clutch plate.The observed physical damage is attributed to the normal wear and tear due to the age of the device, it is unrelated to the ua 16 error message.The platform was further tested including the load cell characterization check which identified a defective load cell.Additionally, intermittent reading with the ir reader was observed, this is caused by a defective processor board.These observation are unrelated to the reported event.After replacement of the load cell, processor board, top cover and clutch plate; the platform passed further testing with no faults found.Historical complaints were reviewed for service information related to the reported complaint and (b)(4) was reported on (b)(6) 2014 for the autopulse platform with serial (b)(4) for the same reported issue.The brake gap was un-seized to resolve the issue.

Event Description

As reported, during shift check the autopulse platform (sn (b)(4)) displays error message user advisory (ua) 16 (timeout moving to take-up position).No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7524405
• MDR Text Key: 108612583
• Report Number: 3010617000-2018-00498
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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: 04/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1