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

Model Number	RMC-A1000
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that their arm device failed to power on during a rescue attempt.Rescue personnel attempted to replace the battery pack; however, the device still did not power on after the replacement.Cpr was administered, but the patient was not resuscitated.
Additional Manufacturer Narrative
Analysis of the arm device's log files, along with statements from the user, revealed that the customer did not follow the instructions for use regarding battery maintenance.Specifically, the customer reported that the batteries were rarely charged, and log data confirmed that the battery packs had not been routinely charged as directed.This lack of regular charging led to full depletion of the batteries, rendering the arm unable to power on during the rescue attempt.As stated in the device user manual: "the battery pack may become unresponsive and non-functional if improperly maintained and left fully depleted.".

• 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: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 22244047
• Report Number: 3003521780-2025-00494
• Device Sequence Number: 20839908
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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
• Device Model Number: RMC-A1000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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: Male