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

Model Number DDU-100

Device Problem No Audible Prompt/Feedback (2282)

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

Event Type  malfunction  

Manufacturer Narrative

Although requested, the aed has not been returned and the cause of the complaint is not known.Should additional information become available, a follow-up mdr shall be submitted.

Event Description

An international distributor reported a customer's aed will not speak and it will not pass a self-test.They reported this did not occur during patient use.

• Brand Name: LIFELINE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILATOR
• Manufacturer (Section D): DEFIBTECH LLC; 741 boston post rd; suite 201; guliford 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: 19140209
• MDR Text Key: 340587617
• Report Number: 3003521780-2024-00336
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 01081509020031
• UDI-Public: 1081509020031
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P160032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

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-100
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1