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

Model Number	RMC-A1000
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported they received their arm compression unit back from a repair claim in late december and after just a couple weeks of use, during testing their arm automated chest compression device powered on but began beeping and flashing it's warning indicator before powering itself off.They reported that this did not occur during patient use.
Additional Manufacturer Narrative
The investigation into the arm unit associated with this complaint is underway and the root cause is not currently known.

• 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: 24251290
• Report Number: 3003521780-2026-00047
• Device Sequence Number: 8233738
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: RMC-A1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 08/26/2024
• 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