BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 8047796 · Received November 7, 2018

    Report

    Report Number
    3009591865-2018-00014
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 7, 2018
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SERVICE CALL WAS PLACED FOR A MEDICAL BED NOT DETECTING CORRECTLY A PATIENT EXITING BED WHILE DETECTION SYSTEM WAS ACTIVATED. THERE WAS NO PATIENT FALL OR FURTHER ADVERSE EVENT ASSOCIATED WITH THE DETECTION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888989 OOK SNOW AC POWERED MEDICAL BED FNL UMANO MEDICAL INC FL36 00670482000067

    Patients

    Seq Age Sex Outcome Treatment
    1