BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 11633166 · Received April 8, 2021

    Report

    Report Number
    3009591865-2021-00004
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 7, 2021
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER WAS CONTACTED BY CUSTOMER ALLEGING THAT THE SIGNAL FOR BED EXITING DETECTION WAS NOT BEING RECEIVED TO THE WALL (FOR RELAY TO THE NURSE CALL SYSTEM). NO RELATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534602 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1