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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

During preventive maintenance on (b)(6) 2024, the autopulse platform sn (b)(6) failed during functional testing due to fault code 16 (timeout moving to take-up position) error message.The root cause of the reported complaint was the defective drivetrain motor, likely attributed to the age of the device.The autopulse platform was manufactured in january 2009 and is 15 years old, well beyond its expected service life of five years.Visual inspection revealed that one of the head restraint wires on the top cover was frayed.The cut head restraint does not render the autopulse platform non-functional.The probable root cause of the observed physical damage is mishandling.The top cover must be replaced to address the issue.During functional testing, the platform displayed fault 16 due to a defective drivetrain motor.The drivetrain motor needs to be replaced to remedy the fault.The autopulse platform was scrapped and will not be repaired.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with sn (b)(6).

Event Description

During preventative maintenance (pm) on (b)(6) 2024, the autopulse platform sn (b)(6) displayed fault code 16 (timeout moving to take-up position) during the functional run-in test.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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18701018
• MDR Text Key: 335299156
• Report Number: 3010617000-2024-00177
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• 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