BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLORENCE

    MDR report key: 14196272 · Received April 25, 2022

    Report

    Report Number
    3009591865-2022-00008
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 25, 2022
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    UDI-DI
    10670482000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED ON MARCH 29TH, 2022 OF AN ALLEGED REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170749 FLORENCE HOSPITAL BED FNL UMANO MEDICAL INC. FL23SE-STD 10670482000040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown