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

Model Number	RMC-A1000
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A professional customer reported that while responding to a patient in cardiac arrest, the arm (automated chest compressor) unit was paused to reposition the piston for improved compression alignment.However, after repositioning the piston, the device would not resume compressions as expected.As a result, the arm unit was removed from the patient, and manual cpr was initiated.
Additional Manufacturer Narrative
Review of the device log files confirms that the arm unit was manufactured on august 22, 2019, and has delivered a total of (b)(4) compressions to date.The log files for the reported event on june 15, 2025, indicate that the device was active for a duration of 14 minutes and 34 seconds, during which it performed 1,285 compressions.Upon analysis of the event data, it was determined that the arm unit would not resume compressions due to improper piston positioning on the patient's chest.The arm device requires firm contact between the piston and the patient's chest to initiate and maintain compressions.If this contact is not properly established, the device will stop compressions or fail to start them altogether.In this case, the user did not reposition the piston firmly on the chest following the pause, resulting in the device being unable to resume compressions.

• 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
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 22497092
• Report Number: 3003521780-2025-00813
• Device Sequence Number: 7087057
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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 Weight: 100 KG