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 11/23/2023

Event Type  malfunction  

Event Description

Defibtech was notified of a rescue attempt where an aed was powered on, it prompted to apply pads, stand clear- do not touch the patient, but did not advise a shock.Shortly after, the fire department arrived with a chest compression device and a different model aed and shocked the patient; however, the patient never regained consciousness.One of the patient's friends at the scene is alleging the battery in the aed was not functioning.It was reported that the gym discarded the battery and pads used in rescue.

Manufacturer Narrative

Examination of aed's history record for this event and surrounding event on (b)(6) 2020 indicated there were no errors.Warnings for a low 9v battery condition detected during self-test beginning around oct 9, 2016 and persisting through feb 19, 2018.No other log activity was indicated until the (b)(6) 2020 event (note the file indicates (b)(6) due to time zone) indicating depleted 9v.The battery pack ((b)(6)) was first used in the aed on (b)(6) 2014 and requires maintenance of the 9v battery to ensure full life (5yr for dbp-1400).After the event, battery serial number (b)(6) was installed, and no errors were reported.The root cause of the failure to power on was due to failure to maintain the device, specifically the battery not maintained.The aed functioned as designed; no aed malfunctions were evident.

• 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: 17130746
• MDR Text Key: 317859921
• Report Number: 3003521780-2023-00014
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2023

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: Lay User/Patient
• Device Model Number: DDU-100
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2064-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 119 KG