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

Model Number DDU-100

Device Problem Power Problem (3010)

Patient Problem Death (1802)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of data files from aed sn(b)(4) reveals an event on (b)(6) 2020 lasting 51 seconds and consisting of 1 analysis period and no shocks delivered.In the first analysis period, the aed encountered a shockable rhythm and appropriately shock was advised.During charging, the aed detected that the charge was taking longer than usual due to the condition of the battery.The dbp-1400 battery in this case had been first used in the aed in january 2015 and is designed for 5 years of use.The battery pack was not only past its expiration, but it was not exercised according to a normal self-testing schedule which among other things, manages the battery condition.The aed charged for approximately 30 seconds and as a consequence of the long charging time, the aed would have announced "battery low" 15 seconds after charging was initiated and then 10 seconds after that.It then appears that during this time the pads were removed from the patient (or the aed) and therefore, by design, the aed canceled the shock.It should be noted that if the patient had remained connected to the aed, then the aed would have continued its attempts to charge for another 10 seconds.Subsequent to the shock being dumped, the aed did not have an orderly shutdown as it appears the battery was ejected from the unit.Examination of the history file from the aed shows that the aed was not maintained properly.The aed is designed to be stored with both the battery inserted and the pads attached in order to perform its automatic self-testing schedule.The self-testing schedule is designed to test the aed to ensure its operational readiness and prolong the life of the battery.The battery used in the rescue was installed in the aed on 1/30/15 and the history file shows that while there were a few periods of time where the aed was performing normal self-testing, it is likely the battery was stored outside of the unit for the majority of its service life and inserted occasionally for testing.Before the november 20, 2020 rescue attempt, the battery was last tested (inserted and removed) 9 months prior, and before that it was in a state of disuse for another 9 months.Given that the battery was 5 years old and not being exercised properly through self-testing, the capacitor charge time was prolonged due to passivation from not being installed / maintained per the manufactures recommendations.

Event Description

A professional customer reported that their aed did not work during a rescue and gave a warning.They also reported that the aed's battery pack was low and expired.

• 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: 11139030
• MDR Text Key: 227491555
• Report Number: 3003521780-2021-00001
• 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: Other
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DDU-100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death