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

Model Number DDU-100

Device Problem Complete Loss of Power (4015)

Patient Problem Unspecified Heart Problem (4454)

Event Date 06/25/2023

Event Type  malfunction  

Event Description

A nonprofit pool/community center reported a rescue attempt on a male patient where the aed powered down after analyzing the patient's rhythm.They reported they pressed the shock button, but nothing happened and that this happened twice following the aed being restarted.During troubleshooting after the rescue, they reported that the aed battery that was used in rescue (serial number (b)(6) was expired, with a labeled expiration date of 2021/05.

Manufacturer Narrative

Review of the device's log files shows it was manufactured in december 2009 and placed in service in may 2010.On september 8, 2019, the aed started reporting a replace 9-volt battery warning during an automated daily self-test.The aed continued to flash its red asi and chirp until october 09, 2019, when the battery became completely depleted.The aed remained off with no evidence of any human interaction to address the aed's condition until the reported rescue attempt on (b)(6) 2023, where the aed could not function due to improper maintenance of the device's battery pack.

• Brand Name: REVIVER
• 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.; 14 commercial st.; branford CT
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 17514917
• MDR Text Key: 321527197
• Report Number: 3003521780-2023-00020
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081259
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DDU-100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2009
• 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 Age: 50 YR
• Patient Sex: Male