BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW ALL

    MDR report key: 11852233 · Received May 19, 2021

    Report

    Report Number
    3009591865-2021-00010
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 19, 2021
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED WOULD NOT GIVE AUDIBLE SIGNAL ON THE BED EXIT DETECTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748091 OOK SNOW ALL HOSPITAL BED FNL UMANO MEDICAL INC 200-0000 00670482000142

    Patients

    Seq Age Sex Outcome Treatment
    1