MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED CARDIAC COMPRESSOR

Model Number	RMC-U2000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the arm unit has not been returned and the cause of the complaint is not known.
Event or Problem Description
A customer reported that their automated cardiac compressor arm unit failed to power on when they attempted to deploy the device during a rescue event.No patient injury, or outcome information was provided.The customer stated that when the unit was later connected to an external power supply, the device powered on; however, it did not initiate compressions.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED CARDIAC COMPRESSOR
• 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: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23586903
• Report Number: 3003521780-2025-01812
• Device Sequence Number: 21181729
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: RMC-U2000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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