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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

During preventive maintenance at customer site, the autopulse platform (sn (b)(4)) failed initial functional testing and displayed user advisory (ua) 2 (compression tracking error) error message.The root was due to defective load cells, likely due to a defective component or mishandling such as drop.During visual inspection, no issue was observed during functional testing, the platform displayed ua 2 error message due to a defective load cell 1 that was confirmed by load cell characterization test.After replacing the load cell 1 to address ua 2, during further functional testing the platform displayed ua 17 (max motor on time exceeded).The root cause of the ua 17 issue was due to the brake gap being out of specification.The brake gap was readjusted to remedy the fault.The platform was manufacture on 16 july 2016 and there was no preventive maintenance performed.After service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.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 sn (b)(4).

Event Description

During preventive maintenance at customer site, the autopulse platform (sn (b)(4)) failed initial functional testing and displayed user advisory (ua) 2 (compression tracking error) error message.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10256078
• MDR Text Key: 198756299
• Report Number: 3010617000-2020-00670
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2016
• 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