MAUDE Adverse Event Report: Defibtech LLC Lifeline Domestic; Automated External Defibrilator

Model Number	DDU-120A-EN
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Lifeline Domestic
• Common Device Name: Automated External Defibrilator
• Manufacturer (Section D): Defibtech LLC; 741 boston post rd; suite 201; guliford 06437
• Manufacturer (Section G): Defibtech LLC; 14 commercial st; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post rd; suite 201; guliford, CT 06437 ; +1(203)453-6654
• MDR Report Key: 50192577
• Report Number: 3003521780-2024-00354
• Device Sequence Number: 21311087
• Product Code: MKJ
• UDI-Device Identifier: 10815098020048
• UDI-Public: 10815098020048
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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-EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2019
• 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