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

Model Number	RMU-A1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that during use on a patient the device was powered on, and the piston lowered 1 inch, then it powered off.Review of the log files from the device show the device was powered on for the reported event data, the battery was then removed and reinstalled several times, the piston was adjusted several times, the device reported a driver fault and finally the unit powered off.The cause of the customer's complaint could not be determined based on the review of the electronic logs alone.Should additional information become available a follow-up mdr shall be submitted.
Event or Problem Description
The customer reported that during use on a patient the device was powered on, and piston lowered 1binch and then the device powered off.They reported that cpr was performed and that the patient survived to hospital.

• 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 CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 20466200
• Report Number: 3003521780-2024-01137
• Device Sequence Number: 7254948
• Product Code: MKJ
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: RMU-A1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White