BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3BR LUNA CPAP MACHINE

    MDR report key: 18640768 · Received February 2, 2024

    Report

    Report Number
    MW5151029
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    December 6, 2023
    Report Date
    January 31, 2024
    Manufacturer
    3B MEDICAL INC
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS ISSUED A 3BR LUNA CPAP MACHINE BY (B)(6). I BEGAN TO SNEEZE INCESSANTLY, WATERY EYES, COUGHING UP VOLUMINOUS MUCUS TINGED WITH BLOOD, AND NOSE RUNNING THAT LED TO CONSTANT BLOWING THAT CAUSE SCANS IN MY NOSE AND BLEEDING. REPORTED THE ADVERSE EFFECTS TO MY DOCTOR AND (B)(6). (B)(6) RECOMMENDATION WAS TO RETURN THE MACHINE BUT THAT THEY DID NOT SELL ANY MACHINES FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092190 3BR LUNA CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC G3 A20 LUNA G3 APAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other AMBIEN.| AZELTINE.| BLOOD PRESSURE MONITOR.| CALCITROL.| CPAP DEVICE. | DONEZIPRIL.| FLONASE NASAL SPRAYS.| MIDODRINE.| OXYGEN 0.2 LITERS.| PRAVASTATIN.| PROZAC.| SINGULAIRE.| SPRIOLACTONE.| SYMBICORT INHALER.| SYNTHROID.| VIT D 50,000 UNITS.| XANAX.