BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAB

    MDR report key: 10841313 · Received November 14, 2020

    Report

    Report Number
    9615102-2020-00115
    Event Type
    Malfunction
    Date Received
    November 14, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 14, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZG
    UDI-DI
    54250892905551
    PMA / PMN Number
    K141936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VYAIRE TECHNICAL SUPPORT REVIEWED THE INFORMATION GIVEN BY THE CUSTOMER AND FOUND THAT THE UNIT HAS A DEFECTIVE ELECTRICAL COMPONENT. UNIT WILL BE SENT TO VYAIRE FAILURE ANALYSIS LABORATORY FOR FURTHER EVALUATION. 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 · 1

    IT IS REPORTED TO VYAIRE MEDICAL THAT THE MICROLAB SPIROMETER EXPERIENCED A BURNT PC BOARD AND A NON-FUNCTIONING LCD. THERE WAS NO PATIENT INVOLVED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306443 MICROLAB SPIROMETER, DIAGNOSTIC BZG VYAIRE MEDICAL FGO MLAB8 SPIROMETER 54250892905551

    Patients

    Seq Age Sex Outcome Treatment
    1