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 Cardiac Arrest (1762); Cardiac Arrest (1762); Stroke/CVA (1770); Myocardial Infarction (1969)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Defibtech is attempting to attain a copy of the electronic data from the aed.To date, however, the electronic data from the aed has not been received.The investigation is currently on-going, and no root cause is known.Should additional information become available a follow-up mdr will be submitted.

Event Description

It was reported that on or about (b)(6) 2016, the patient suffered a heart attack and cardiac arrest.Prior to the arrival of paramedics, several employees assisted the patient by administering cpr and by using two automated external defibrillators.It was reported that both defibrillators failed to operate due to lack of maintenance and/or battery failure.This mdr is being filed for the first unit associated with this event.The second unit associated with this event is being filed under mdr 3003521780-2018-00013.

Manufacturer Narrative

Evaluation of the event file for aed sn (b)(4).Reveals two event records on (b)(6) 2016 lasting a total of approximately 13 seconds and consisting of no analysis periods and no shocks delivered.In the 1st record, the aed was powered on for approximately 4 seconds before being powered down by the user.Approximately 11 seconds later, the aed was powered on a second time, for approximately 9 seconds, before being powered down by the user.In both events, the pads were never applied to the patient.The history record for this event also indicates there were warnings present on the aed before this (b)(6) 2016 event.On (b)(6) 2012 during a daily self-test, the aed detected a low 9-volt battery and began flashing its red asi and chirping to announce this warning.The asi was flashing red and the aed was chirping from (b)(6) 2012 through (b)(6) 2012, when the 9-volt battery became fully depleted and the aed stopped chirping, the asi stopped blinking, and the aed stopped performing self-tests.On (b)(6) 2012, the aed was turned on by a user for 6 seconds, it performed a power on self-test, and upon the user powering the unit down, the aed would have announced "replace 9-volt battery".There is no indication that the user attempted to maintain the unit or address the 9-volt battery.From (b)(6) 2012 through (b)(6) 2016, the aed was not indicating it was operationally ready, and there was no evidence in the electronic data of any user interaction to address the aed's condition or perform any maintenance activities on the aed.Despite the failure to properly maintain the device, the aed functioned as designed during the (b)(6) 2016 event.

• 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
• MDR Report Key: 8034864
• MDR Text Key: 127562503
• Report Number: 3003521780-2018-00012
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K013896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DDU-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Death