MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number DDU-100

Device Problem Failure to Power Up (1476)

Patient Problem Unspecified Heart Problem (4454)

Event Date 03/29/2024

Event Type  malfunction  

Event Description

A customer reported their aed prompted "replace battery pack now warning" during a rescue attempt.They stated that they tried to use the aed anyway but received a garbled message and blinking lights.They stated the aed was not able to advise any shocks and although they were able to briefly achieve rosc, the patient was not resuscitated.

Manufacturer Narrative

Although requested, the log files from the device have not been provided and the cause of the complaint is not known.Should additional information become available, a follow-up mdr shall be submitted.

• Brand Name: LIFELINE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 14 commercial st.; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 19198739
• MDR Text Key: 341374916
• Report Number: 3003521780-2024-00388
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10815098020000
• UDI-Public: 10815098020000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160032
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DDU-100
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male