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 Atrial Fibrillation (1729)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The ddu-100 series aeds are designed to be stored with the pads connector already installed.This reduces the time needed to set up and start treatment in an emergency.If pads are not connected, the aed will attempt to alert the user by flashing its red asi and chirping.The customer confirmed that they stored the aed in a wall cabinet without the pads being connected and checked it monthly to verify the aed was flashing red and chirping.Storage of the aed without pads attached reduced the life of the battery pack which was the cause for the aed not powering on during the (b)(6) 2023 rescue attempt.

Event Description

A health and rehabilitation center reported that when responding to a patient who was breathing and responsive, a nurse connected pads to the aed, the pads to the patient and tried to turn aed on, but the aed would not power on.Cpr was not performed, and the patient was taken to the hospital in an ambulance.The patient's outcome was not known.When asked about the maintenance of the device, the customer stated that the aed is stored in a wall cabinet without pads being connected and it is checked monthly by maintenance to verify the aed was flashing red and chirping.

• 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.; 741 boston post road; suite 201; guilford 06437
• Manufacturer Contact: ian white ; 741 boston post road; suite suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 16634891
• MDR Text Key: 312219187
• Report Number: 3003521780-2023-00006
• 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: 02/27/2023

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 Operator: Health Professional
• Device Model Number: DDU-120
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 79 KG