BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNA G3

    MDR report key: 17499148 · Received August 9, 2023

    Report

    Report Number
    MW5122879
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    August 6, 2023
    Report Date
    August 7, 2023
    Manufacturer
    3B MEDICAL INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A NEW LUNA G3 CPAP MACHINE FROM SUPERCARE INC. THE MACHINE EMITTED A VERY STRONG PVC SMELL, INDICATIVE OF VOCS IN FORM A POLYVINYL CHLORIDE (PVC) FUMES AND FORMALDEHYDE), BOTH KNOWN CARCINOGENS. THIS OUTGASSING OCCURRED ONLY WHEN THE MACHINE WAS RUNNING. IT APPEARS THE VOCS WERE COMING FROM THE INTERNALS OF THE MACHINE, BECAUSE WHEN THE HOSE WAS REMOVED THE OUT GASSING EFFECT DID NOT CHANGE. THE EMISSION OF VOCS FROM A MEDICAL DEVICE CONSTITUTES A VERY SERIOUS HEALTH HAZARD, PARTICULARLY WHEN THE EMISSION GETS INTO THE PATIENT'S LUNGS UNMITIGATED. THESE MACHINES SHOULD BE TAKEN OFF THE MARKET IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049022 LUNA G3 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC. LG3600

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male