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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

During the service performed on (b)(6) 2024, the autopulse platform (sn (b)(6) failed during functional testing due to a fault 16 (timeout moving to take-up position) error message.The root cause of the reported complaint was the defective drivetrain motor, likely due to a defective component.Upon visual inspection, the front and bottom enclosures were observed to be damaged and appeared to have the characteristics of user mishandling, such as a drop.The front and bottom enclosures were replaced to remedy the observed issue.The platform failed the initial functional testing due to fault code 16.The autopulse platform did not achieve the target depth for take-up within the specified time (~5 secs) due to the slipped bushing as a result of the failing drive train motor.The slipped bushing will cause the drive train motor to seize, making it unable to rotate or making a grinding noise during take-up.To remedy the issues, the failed drive train motor was replaced.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for autopulse platform with sn (b)(6).

Event Description

During the service performed on (b)(6) 2024, the autopulse platform (sn (b)(6)) failed during functional testing due to a fault 16 (timeout moving to take-up position) error message.No patient involvement.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18701017
• MDR Text Key: 335411862
• Report Number: 3010617000-2024-00180
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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