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

Model Number	RMC-U2000
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2026
Type of Reportable Event	Death
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 professional user reported that during a rescue attempt on (b)(6) 2026 involving a patient who had attempted suicide, the arm acc device functioned as intended upon initial placement but ceased performing chest compressions.The customer stated this has occurred during multiple rescue attempts.Responders sometimes attempted to readjust the piston, though not consistently.A battery replacement was attempted but did not resolve the issue.The customer reported motor-related warnings in the device history.They also noted that no service indicator light was present upon power-on, but that the service indicator may illuminate intermittently during use.

• 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
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 24719371
• Report Number: 3003521780-2026-00413
• Device Sequence Number: 5777638
• Product Code: DRM
• UDI-Device Identifier: 00815098020812
• UDI-Public: (01)00815098020812
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RMC-U2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White