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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During shift check, customer reported that the autopulse platform (serial # (b)(4)) powers off by itself with several good fully charged autopulse li-ion batteries.No patient involvement.

Manufacturer Narrative

The reported complaints of the autopulse platform (serial # (b)(6) displayed user advisory - "(ua)16" (timeout moving to take-up position) and "(ua)17" (max motor on time exceeded) error messages were confirmed during the functional test and archive data review.The root cause of the error messages was due to damaged drive train motor in which is likely attributed to normal wear and tear.The returned autopulse platform was manufactured in january 2012 and it is 8 years old, well past beyond its expected serviceable life of 5 years.The power issue that was also reported was not confirmed, autopulse platform powers on with a new autopulse li-ion battery.Unrelated to the reported complaint, a cracked short black cover was observed on the returned autopulse platform during visual inspection.This type of physical damaged is likely due to mishandling.The cover was replaced to remedy the damaged cover issue also, no brake operation was found.This type of faulty component was likely due to normal wear and tear.The power distribution board (pdb) was replaced to address the brake issue.During archive data review, multiple "ua16" and "ua17" error codes were observed on the reported event date.Thus, confirming the reported complaint.The initial functional testing of the returned autopulse platform failed due to "ua16" and "ua17" displayed during compressions on a manikin.Thus, confirming the reported complaint.To remedy the reported error messages issues, the drive train motor assembly was replaced.After service completion, 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 ap platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(6).

• 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: 9645093
• MDR Text Key: 181981259
• Report Number: 3010617000-2020-00079
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: 01/10/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1