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

Model Number	RMC-A1000
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the user reported that the arm unit stopped performing compressions and flashed a battery warning, no evidence of a battery issue was found in the device log files.The logs indicated that the unit issued a warning due to an operator setup error, as the device was unable to detect an adequate patient load and required adjustment in accordance with the instructions for use (ifu).In this case, a motor timeout error was recorded.This error may occur when the device is unable to complete compressions within the expected cycle time due to slower than normal piston retraction speed.Such behavior can result from patient-specific dynamics or physiology, such as weak or delayed chest recoil.These issues may be further exacerbated when the patient interface pad is not properly adjusted to maintain firm contact with the patient's chest.No device malfunction was identified, and the unit resumed normal operation after the battery was removed and reinstalled.The investigation supports that the device performed as designed, and the event was attributed to use conditions outside of the ifu.
Event or Problem Description
A professional customer reported that during a patient rescue event, the automated resuscitation machine (arm) unit unexpectedly ceased chest compressions and began flashing a battery warning indicator.To the crew using the device, it appeared as though the unit had overheated and shut down.After the rescue, the battery was removed and reinstalled, at which point the device resumed normal operation, and the battery appeared to be functioning normally.No patient harm was reported in association with this event.

• 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: 22079947
• Report Number: 3003521780-2025-00454
• Device Sequence Number: 8702254
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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-A1000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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