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

Model Number	RMC-E1000
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the arm's internal log files did not identify a definitive cause for the battery pack not charging.No anomalies or fault codes related to charging behavior were recorded in the logs.The arm device and associated battery pack were requested to be returned for further evaluation and testing.However, as of this report, the units have not been returned.Therefore, the root cause of the charging failure remains unknown.
Event or Problem Description
An international distributor reported that their customer experienced an issue with the arm device battery.The battery would not charge, and a continuous flashing red light was observed.Additionally, the device would not power on or function while connected to the charger.The customer confirmed that this issue did not occur during patient 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 CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 22287301
• Report Number: 3003521780-2025-00504
• Device Sequence Number: 18366052
• Product Code: DRM
• UDI-Device Identifier: 10815098020819
• UDI-Public: (01)10815098020819
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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-E1000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: Unknown