BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 25024118 · Received April 28, 2026

    Report

    Report Number
    3010880718-2026-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 8, 2026
    Manufacturer
    GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
    Product Code
    CAF
    UDI-DI
    00822383579160
    PMA / PMN Number
    K980074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A COMPLAINT REPORTING "WAS USING THE DEVICE, THE DEVICE QUIT WORKING AND SMOKE CAME OUT OF THE SIDES WHERE THERE ARE HOLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41099 DRIVE COMPRESSOR NEBULIZER CAF GLOBALCARE MEDICAL TECHNOLOGY CO., LTD MQ5900 13M370132 00822383579160

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female