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

Model Number	RMC-U2000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the arm has not been returned and the cause of the complaint is not known.
Event or Problem Description
The arm (rmu-1000) chest compression device reportedly exhibited frame cracking when the user attempted to apply the device to the patient.The unit could not be successfully applied, and the responders transitioned to manual cpr, resulting in rosc and survival to hospital.Although the event occurred during patient treatment, there is no evidence that the device malfunction contributed to or could have caused death or serious injury, as effective resuscitation was achieved by alternate means.Accordingly, this event does not meet mdr reportability criteria as an adverse event under 21 cfr 803.3.The incident will be submitted as a product problem mdr out of an abundance of caution, due to the mechanical damage (cracked frame) observed during attempted use.
Event or Problem Description
The arm xr chest compression device reportedly exhibited frame cracking when the user attempted to apply the device to the patient.The unit could not be successfully applied, and the responders transitioned to manual cpr, resulting in rosc and survival to hospital.Although the event occurred during patient treatment, there is no evidence that the device malfunction contributed to or could have caused death or serious injury, as effective resuscitation was achieved by alternate means.Accordingly, this event does not meet mdr reportability criteria as an adverse event under 21 cfr 803.3.The incident will be submitted as a product problem mdr out of an abundance of caution, due to the mechanical damage(cracked frame) observed during attempted 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: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 23429778
• Report Number: 3003521780-2025-01716
• Device Sequence Number: 12822541
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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-U2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Female