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 Death (1802)

Event Date 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis of the electronic data files from aed serial number (b)(4) identified that the aed entered into service on may 06, 2020, but was not set up per the device user instructions; specifically, when the aed was placed into service, the pads were not connected to the aed.Once in service, the aed detected that the pads were not connected and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash its red asi and chirp, without any evidence of human interaction to address the unit's condition, until (b)(6) 2020, when the aed's battery pack became fully depleted.Approximately four weeks later, on (b)(6) 2021, the aed was deployed for the rescue attempt but would not power on due to the depleted battery pack.

Event Description

A customer reported that during a rescue attempt by professionals, the aed would not power on.They reported that no shocks were advised and the patient was not resuscitated.

• 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 201; guilford 06437 ; 2034536654
• MDR Report Key: 11304686
• MDR Text Key: 232390651
• Report Number: 3003521780-2021-00002
• 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: 02/09/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR