BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RMU-2000 ARM XR CHEST COMPRESSION DEVICE

    MDR report key: 20106798 · Received August 29, 2024

    Report

    Report Number
    MW5159049
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    DEFIBTECH LLC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A EMS SERVICE THAT USES 2 DEFIBTECH RMC-1000 AUTOMATIC COMPRESSION DEVICES FOR CPR AND FOR NO REASON, THE MOTOR STOPS AND CANNOT BE RE-STARTED AND MANUAL CPR IS RESTARTED. WE ASSUMED IT WAS A BATTERY ISSUE, BUT THAT IS NOT THE CASE AND HE HAVE NOT REACHED OUT TO THE MANUFACTURER FOR CORRECTIVE ACTION, I RECENTLY RECEIVED AN EMAIL IN REFERENCE TO THE RMU-2000 ARM XR CHEST COMPRESSION DEVICE FROM DEFIBTECH AND HAVE CONCERNS IT ACTUALLY IS AFFECTING THE MODEL I OWN. REF REPORT: MW5159048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369485 RMU-2000 ARM XR CHEST COMPRESSION DEVICE COMPRESSOR, CARDIAC, EXTERNAL DRM DEFIBTECH LLC. RMU-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other