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

Model Number	DDU-120A
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their aed's asi is flashing red and prompting a "replace battery pack now" warning.The customer did not report this occurring during patient use.
Additional Manufacturer Narrative
Analysis of the aed's log files identified that the customer's failure to promptly address red asi warnings reduced battery life expectancy.On (b)(6) 2026 the aed identified a service code during an automated self-test and attempted to alert the user by flashing its red asi and chirping.The aed continued to flash and chirp until (b)(6) 2026 when the battery pack was measured at a critically low state and the aed began reporting replace battery pack now.The aed continued to flash and chirp until (b)(6) 2026 when the battery was ejected and a replacement battery pack was installed.Once the new battery was installed and a manual self-test performed the aed functioned as designed and was able stay in service.

• 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: 50935594
• Report Number: 3003521780-2026-01647
• Device Sequence Number: 18825041
• Product Code: MKJ
• UDI-Device Identifier: 00815098020041
• UDI-Public: (01)00815098020041
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-120A
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2018
• 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