BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNA G3, APAP

    MDR report key: 22771565 · Received August 11, 2025

    Report

    Report Number
    MW5174307
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 5, 2025
    Manufacturer
    3B MEDICAL INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LUNA G3, 3B UNIT SEVERELY OVERHEATED WHILE I WAS SLEEPING. IT WAS SO HOT I COULD NOT TOUCH IT OR MY HAND WOULD HAVE BEEN BURNED. IT WAS THE TRANSFORMER UNIT, I THINK, THAT WAS HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271013 LUNA G3, APAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC. G3A20

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male