BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW ALL

    MDR report key: 14269113 · Received May 3, 2022

    Report

    Report Number
    3009591865-2022-00010
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 2, 2022
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Removal / Correction Number
    RES#90058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DISTRIBUTER CONTACTED TECHNICAL SERVICE OF THE MANUFACTURER TO REPORT AN ISSUE WITH THE MOTORIZED WHEEL SYSTEM OF A HOSPITAL BED. HE MENTIONED THAT THE BED CONTINUED TO MOVE FORWARD EVEN THE TRIGGER (ACCELERATOR) WAS RELEASED TO STOP THE WHEEL MOVEMENT. THE BED WAS BEING OPERATED BY AN EMPLOYEE OF THE HOSPITAL AND IT WAS UNOCCUPIED (NO PATIENT) AT THE TIME OF THE INCIDENT. THERE WAS NO INJURY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500844 OOK SNOW ALL HOSPITAL BED FNL UMANO MEDICAL INC. 200-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown