MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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 02/27/2024

Event Type  malfunction  

Event Description

During the shift check, the autopulse platform (sn (b)(6)) was unable to retract the lifeband, making a "popping & growling" sound.The customer did not report any advisory messages.No patient involvement.

Manufacturer Narrative

The customer reported that the autopulse platform (sn (b)(6)) was unable to retract the lifeband, making a "popping & growling" sound was confirmed during the functional testing.The root cause of the issue was a defective drive train motor, likely attributed to a failed component.Upon visual inspection, the top cover and the front enclosure were observed to be damaged, unrelated to the reported complaint, and appeared to have the characteristics of user mishandling, such as a drop.The top cover and the front enclosure need to be replaced to remedy the observed issue.A review of the archive data was performed, and it showed a fault code 16 (timeout moving to take-up position) occurred around the reported event date, unrelated to the reported complaint.The platform failed the initial functional testing due to fault code 16, unrelated to the reported complaint.The autopulse platform did not achieve the target depth for take-up within the specified time (~5 secs) due to the spun-out internal bearing as a result of the failing drive train motor.To remedy the issues, the failed drive train motor needs to be replaced.Waiting for customer approval for 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® 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 18965303
• MDR Text Key: 338467252
• Report Number: 3010617000-2024-00243
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• 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: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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