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); Death (1802); 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 second unit associated with this event.The first unit associated with this event is being filed under mdr 3003521780-2018-00012.

• 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 CT 06437
• Manufacturer Contact: ed horton ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 8034939
• MDR Text Key: 127563160
• Report Number: 3003521780-2018-00013
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• 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