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

Model Number DDU-120

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting of the device with the customer identified that the aed was in service without the pads connected to the aed.The ddu series aeds are designed to be stored with the pads connector already installed.This simplifies the procedure for deploying and operating the device in an emergency.During the aed's automated self-test, the aed would have identified that the pads were not connected and attempted to alert the user by flashing its red asi and chirping.The aed would continue to chirp and flash until the aed's condition is addressed or the battery pack becomes completely depleted.The cause of the aed not powering on was related to a failure to set-up the aed and maintain the battery pack.

Event Description

A customer reported that their aed's previous battery pack was expired, they are not storing the aed with pads connected and the asi is blank.They reported that this did not occur during patient use.

• 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: 19198743
• MDR Text Key: 341265562
• Report Number: 3003521780-2024-00385
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10815098020048
• UDI-Public: 10815098020048
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DDU-120
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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