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

Model Number DDU-100

Device Problem Failure to Power Up (1476)

Patient Problems Death (1802); Suicidal Ideation (4429)

Event Date 09/19/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the electronic data from aed serial number (b)(4) identified that the device was placed in service on december 14, 2018 with battery pack serial number (b)(4).On march 24, 2019 during a routine self-test, the aed detected a possible problem and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash its red asi and chirp until january 02, 2020 when the main battery pack became fully depleted or was ejected.There was no evidence in the electronic data of any human interaction to address the aed's condition.The aed remined off for an additional 8 months with no evidence of any human interaction until the reported rescue attempt on (b)(6) 2020 where the aed would not power on due to the depleted battery pack.Troubleshooting of the aed with a replacement battery by defibtech personnel over the phone identified that the aed was able to successfully pass a manually initiated self-test indicating that the aed is operationally ready.The cause of the event was identified as a failure to maintain the aed; specifically, a failure to maintain the aed's main battery pack.The customer was informed of the proper maintenance activities for this device and a replacement battery pack was sent.The aed currently remains in service.

Event Description

A police department reported that during a rescue attempt on a patient who had committed suicide by hanging, the aed would not power on.It was further reported that even though ems arrived a few minutes later, 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: 10822555
• MDR Text Key: 217651606
• Report Number: 3003521780-2020-00009
• Device Sequence Number: 1
• Product Code: MKJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2020

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: Other
• Device Model Number: DDU-100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2018
• 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: 21 YR