MAUDE Adverse Event Report: Defibtech, L.L.C. Lifeline; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	DDU-100E
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
Event or Problem Description
A customer reported that their aed's asi is flashing red, and the aed will not power on.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
The customer reported that the aed would not power on and that the aed's asi was flashing red.A flashing red asi indicates that the aed is off and that the aed or battery pack requires attention.Per the instructions for use, if the asi is flashing red and/or the unit emits a periodic beep, the unit may require servicing, the battery pack may be nonfunctional, or the defibrillation pads may not be connected to the device.There was no indication that the aed was stored without the pads attached.The aed was unable to complete a power on self-test during troubleshooting with customer service.Because a spare battery pack was not available, no further troubleshooting could be performed, and the device log files could not be retrieved.The customer was referred to an authorized distributor to purchase a replacement battery pack.

• Brand Name: Lifeline
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; +1(203)453-6654
• MDR Report Key: 50755247
• Report Number: 3003521780-2026-01585
• Device Sequence Number: 9414871
• Product Code: MKJ
• UDI-Device Identifier: 00815098020034
• UDI-Public: (01)00815098020034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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-100E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2022
• 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