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

Model Number	RMC-A1000GG
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the event summary report from the device identified an event on 10-11-2024 lasting 58 minutes with the device performing a total of 4,111 compressions.The summary report shows the device was deployed at 19:40:23 and functioned properly for nearly 27 minutes until 20:07:16 at which point it stopped compressions, as designed, to allow for a piston adjustment to the patient's chest.Instead of adjusting the piston, the user pressed the pause and run compression buttons multiple times.At 20:13:13 the device piston was adjusted to the patient's chest and compressions resumed until 20:24:57 when the device again indicated a need for piston adjustment.The adjustment to the piston was not made, and the device was subsequently powered off.The analysis concludes that the issue likely resulted from a lack of user training.As defined in the device ifu, "compressions may also stop or fail to start because the piston requires adjustment to the patient's chest.The acc will indicate that piston adjustment is required by blinking the adjust up/down leds.Press the pause button to clear the piston adjustment error condition.Readjust the piston using the adjust up/down buttons so that it is making firm contact with the patient's chest.To resume compressions, push the run continuous button or the run with breaths button.".
Event or Problem Description
It was reported by a customer that during a rescue attempt, the device stopped compressions.They reported that they tried replacing the battery pack during the rescue attempt, but the issue continued.They further reported that the patient was not resuscitated.

• Brand Name: LIFELINE
• Common Device Name: 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: 20738647
• Report Number: 3003521780-2024-01285
• Device Sequence Number: 20927043
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/21/2024

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
• Operator of Device: Other
• Device Model Number: RMC-A1000GG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown