BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMAX

    MDR report key: 16963211 · Received May 19, 2023

    Report

    Report Number
    2021710-2023-17704
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 19, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZG
    UDI-DI
    10846446021288
    PMA / PMN Number
    K942211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS A BURNING SMELL AND THE POWER CABLE MELTED AT ONE OF THE PRONGS ON THE OBS, INSTRUMENT ASSY V62J AUTOBX.THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016612 VMAX SPIROMETER, DIAGNOSTIC BZG VYAIRE MEDICAL INSTRUMENT ASSY V62J AUTOBX 10846446021288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown