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 Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during initial functional testing and archive data review.To remedy the issue, the driveshaft was rotated back to the home position.The likely root cause of the issue was due to user error.Per the autopulse user guide instruction, to clear user advisory (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.During initial functional testing, the autopulse platform displayed user advisory (ua) 45 error message upon powering on.The archive data review showed the occurrence of the user advisory (ua) 45 error message on the reported complaint date.The drive shaft was rotated to the home position to clear the user advisory (ua) 45 error message.Unrelated to the reported complaint, a cut patient head restraint wire was observed on the returned autopulse platform during visual inspection.This type of physical damage is likely due to mishandling, the patient head restraint wire could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.The top cover was replaced to address the damaged restraint wire issue.Also, unrelated to the reported complaint, during visual inspection noticed a sticky clutch.The clutch plate was deburred to address the sticky clutch problem.The cause for the observed sticky clutch problem was due to normal wear and tear.The autopulse platform was manufactured in september 2014 and is almost 6 years old, beyond the expected service life of 5 years.Following service, the autopulse platform passed 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 autopulse platform passed the final testing without any fault or error.Historical records were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse platform with serial number (b)(4).

Event Description

It was reported that the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• 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: 10063901
• MDR Text Key: 191478782
• Report Number: 3010617000-2020-00486
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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