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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) does not power on was confirmed during functional testing.The root cause of the power issue was due to loose connection between the power switch cable and processor board likely due to wear and tear.The autopulse platform is a reusable device and was manufactured in june 2015 and is 6 years old, past its expected service life of 5 years.Upon visual inspection, a cracked front enclosure was observed, unrelated to the reported complaint.This physical damage is likely attributed to user mishandling such as a drop.Archive data review showed no significant issues.Initial functional testing could not be performed due to platform not powering on, thus confirming the reported complaint.The connection between the power switch cable and processor board was loose.The power switch cable and processor board were replaced to remedy the reported problem.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the surface of the clutch rotor, likely attributed to wear and tear.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.After service, the autopulse 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.The autopulse passed all other functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

Customer reported that the autopulse platform (serial # (b)(4)) does not power on with several good fully charged autopulse li-ion batteries.It is unknown where the problem occurred.However, 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 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 12272431
• MDR Text Key: 264929221
• Report Number: 3010617000-2021-00681
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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