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

Model Number	DDU-100E
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
An international distributor reported a customer's aed will not speak.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Although requested, additional information necessary to investigate the complaint remains unavailable, and the root cause is unknown.Should additional information become available, it will be evaluated and a supplemental report submitted, as appropriate.

• 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: 50714653
• Report Number: 3003521780-2026-01590
• Device Sequence Number: 21482566
• Product Code: MKJ
• UDI-Device Identifier: 00815098020034
• UDI-Public: (01)00815098020034
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2020
• 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