BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBLENDER

    MDR report key: 13372065 · Received January 27, 2022

    Report

    Report Number
    2021710-2022-15353
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 3, 2022
    Report Date
    January 3, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    BZR
    UDI-DI
    10846446002225
    PMA / PMN Number
    K883038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT NUMBER (B)(4). OVERHAUL AND CALIBRATION WAS PERFORMED ON (B)(6) 2022 IN ACCORDANCE WITH THE DATA-RECORDING SHEET 91639. THE VYAIRE MEDICAL GMBH CERTIFIED THAT THE EQUIPMENT SERIAL #(B)(6) HAD PASSED ALL OPERATIONAL SPECIFICATIONS AND WAS CERTIFIED FOR CLINICAL USE.

    Description of Event or Problem · 0

    A VYAIRE REPRESENTATIVE REPORTED THE UNIT HAS A LEAK ON THE MICRO-BLENDER COMPONENT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45596 MICROBLENDER MIXER,BREATHING GASES,ANESTHESIA INHALATION BZR VYAIRE MEDICAL INC. MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO 10846446002225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown