BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MACHINE

    MDR report key: 17924030 · Received October 11, 2023

    Report

    Report Number
    MW5146860
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    April 15, 2023
    Report Date
    October 6, 2023
    Manufacturer
    3B MEDICAL INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A CPAP MACHINE FOR MY SLEEP APNEA FROM (B)(4). THEY WERE RECOMMENDED BY MY DOCTOR. SINCE (B)(6), THE MACHINE HAS BEEN DEFECTIVE AS THE WATER STORAGE COMPONENT DOES NO WORK PROPERLY AND CAUSES AIR LEAKAGE AND PRESSURE CHANGES. THIS HAS BEEN OCCURRING SINCE (B)(6), 2023. I HAVE CALLED AT LEAST 10 TIMES AND AM TOLD THAT SOME SPECIALIST WILL CALL, BUT THERE IS NO FOLLOW UP AND RESOLUTION. THIS HAS BEEN IMPACTING MY SLEEP QUALITY, WHICH INCREASES MY OVERALL RISK AS I HAVE HYPERTENSION. I HAVE REQUESTED THAT EITHER THE PROBLEM BE FIXED OR MACHINE REPLACED, BUT HAMPTON HOMECARE HAS NOT DONE NEITHER AND NOBODY RETURNS MY CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038380 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC. LUNA G3 320

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Disability TAKING MEDICINE FOR BP AND CHOLESTEROL.