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

Model Number	DDU-2200
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the aed nor its log files have not been provided and the cause of the complaint is not known.Should additional information become available a follow-up mdr shall be submitted.
Event or Problem Description
A distributor reported their customer's aed would not power on.They reported that this did not occur during patient use.
Additional Manufacturer Narrative
The reported problem could not be confirmed.The distributor reported that their customer's aed would not power on.However, analysis of the aed's log files found that on 12/01/23 the aed began alerting a service code 7080 attributed to unintentional pressing of buttons while in storage.The aed attempted to alert the user by flashing red and chirping.The aed continued to flash and chirp until 12/20/23, when a replacement battery was installed.Although requested, the aed has not been returned and the cause of the complaint is not known.

• Brand Name: LIFELINE
• Common Device Name: 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: 18540018
• Report Number: 3003521780-2023-00312
• Device Sequence Number: 6402646
• Product Code: MKJ
• UDI-Device Identifier: 10815098020192
• UDI-Public: 10815098020192
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Model Number: DDU-2200
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown