BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 16275500 · Received January 31, 2023

    Report

    Report Number
    9616873-2023-00001
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    March 22, 2022
    Report Date
    April 6, 2022
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    KNN
    UDI-DI
    00822383519098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE END USER CALLED TO REPORT A "5 BEEP CODE" ON THE UNIT'S BATTERY. THIS ERROR CODE BELONGS TO THE ABNORMALITY OF THEELECTROMAGNETIC BRAKE CIRCUIT. IF IT IS IN THIS STATE AND THE CLUTCH HANDLE IS RELEASED, IT WILL BE IN A NON-BRAKING STATE, RESULTING IN THEPOSSIBILITY OF ROLLOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378105 DRIVE MEDICAL POWER, POV, 4 WHEEL KNN WU'S TECH CO., LTD. SFSCOUT4 00822383519098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other