MAUDE Adverse Event Report: DEFIBTECH LLC REVIVER; AUTOMATED EXTERNAL DEFIBRILATOR

Model Number DDU-120

Device Problems Failure to Power Up (1476); No Audible Prompt/Feedback (2282)

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

Event Type  malfunction  

Manufacturer Narrative

This aed nor its electronic log files were returned and thus the root cause could not be determined.Based on the fact that this aed is well beyond its 10-year design life, and the reported problem, the customer was advised to remove the aed from service.Should additional information become available a follow-up mdr shall be submitted.

Event Description

The customer reported that the aed wouldn't turn on, wouldn't speak, but the lights flash.The battery pack was reported as being ok, being tested in another unit.This event did not occur during patient use.

• Brand Name: REVIVER
• Type of Device: AUTOMATED EXTERNAL DEFIBRILATOR
• Manufacturer (Section D): DEFIBTECH LLC; 741 boston post rd; suite 201; guliford CT 06437
• Manufacturer (Section G): DEFIBTECH LLC; 14 commercial st; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post rd; suite 201; guliford, CT 06437 ; 2034536654
• MDR Report Key: 19140188
• MDR Text Key: 340574698
• Report Number: 3003521780-2024-00322
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DDU-120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1