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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2024, the returned autopulse platform (b)(6) was serviced for preventive maintenance (pm).The autopulse platform passed the initial functional testing without any fault or error.However, during further testing of the drivetrain motor, the investigation revealed that the drivetrain motor brake assembly air gap was too wide, and out of the specification.The brake gap could not be adjusted and continued to open out of specification.The potential root cause is due to a defective drivetrain motor, likely attributed to a defective component as the drivetrain was replaced on (b)(6) 2020, during platform service.The failed drivetrain motor needs to be replaced to remedy the issue.During visual inspection, it was noted that one of the head restraints was cut from the top cover of the autopulse platform, likely attributed to mishandling.The 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 cut or damaged head restraint does not render the autopulse platform non-functional.The top cover needs to be replaced to address the observed damage.In addition, found the encoder drive shaft does not rotate smoothly, and exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is characteristic of normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring or replacement of the clutch plate needs to be performed to remedy the encoder driveshaft issue.Also, noticed a torn load plate cover that affects the watertight seal.The probable root cause for the observed physical damage was user mishandling.The load plate cover needs to be replaced to address the damage.Further visual inspection revealed a bent battery lock.The observed physical damage appeared to be the characteristic of user mishandling.The battery lock needs to be adjusted to address the observed issue.Waiting for customer approval for service.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with (b)(6).

Event Description

On (b)(6) 2024, during preventive maintenance, the autopulse platform (b)(6) failed functional testing as the drivetrain motor brake assembly air gap was out of specification.No patient involvement.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19016806
• MDR Text Key: 339095776
• Report Number: 3010617000-2024-00333
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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