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 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform (sn 37722) displayed fault 16 (timeout moving to take-up position) was confirmed during the functional testing and the archive data review.The root cause of the reported complaint was a malfunctioning motor controller, which was likely attributed to a failed component.Upon visual inspection, no physical damage was observed.The archive data indicated fault 16 around the reported event date, confirming the reported complaint.Further archive review indicated fault 08 (motor controller fault detected) was reproduced during the functional testing.Fault 08 was not reported by the customer but was related to the reported complaint of fault 16.The autopulse platform failed functional testing due to fault 08 displayed upon powering on.Technical investigation revealed a malfunctioning motor controller as a root cause of fault 16 and fault 08.The motor controller was replaced to address the reported complaint.Following service, the autopulse platform passed the run-in and final tests without fault or error.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).

Event Description

During the resuscitation of a patient, the autopulse platform, sn (b)(6) displayed fault 16 (timeout moving to take-up position).The crew started manual cpr immediately, and care was not interrupted.The crew attempted to troubleshoot after the call by using three lifebands.Each time, the platform failed to retract and displayed fault 16.No consequences or impacts on the patient.

• 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: 18668343
• MDR Text Key: 334904674
• Report Number: 3010617000-2024-00104
• 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: 02/08/2024

1 Device was Involved in the Event

• 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: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse