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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message and drive shaft wouldn't turn when the customer tried to rotate it.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The customer's complaint that the autopulse platform (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message and the drive shaft wouldn't turn was confirmed during the functional testing and the archive data review.The root cause of the reported complaint was a failed drive shaft, likely attributed to failed components.Upon visual inspection, unrelated to the reported complaint, a crack across the screw well area of the front enclosure handle and a broken/deformed top cover bottom corner were noted.The observed damages appear to be the characteristics of the harsh impact caused by user mishandling, such as a drop.The damaged parts need to be replaced to address the observed physical damages.The archive data indicated multiple ua45 errors on the reported event date, confirming the reported complaint.Upon further review, unrelated to the reported complaint, a ua02 (compression tracking error) error was noted on the reported event date.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse hangtag - advisory codes description and action, user advisory 2 indicates that autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position or if the lifeband is opened during active operation.The recommended actions for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure the patient and the band are correctly aligned, and press restart.The autopulse platform failed functional testing due to ua45 displayed upon powering on.Technical investigation revealed that the driveshaft could not be rotated, confirming the reported complaint.The integrated encoder gearbox and shaft lock plunger need to be replaced to address the reported complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with sn (b)(6).

• 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: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18253150
• MDR Text Key: 329709223
• Report Number: 3010617000-2023-01014
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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