BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 7135664 · Received December 20, 2017

    Report

    Report Number
    3009591865-2017-00005
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    December 12, 2017
    Report Date
    December 20, 2017
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT FALL WAS REPORTED TO THE MANUFACTURER WHEN USER PLACED A CALL FOR TECHNICAL VERIFICATIONS RELATIVE TO THE PRODUCT. VERIFICATIONS CONFIRMED THE BED WAS PERFORMING TO SPECIFICATIONS. THE ESTABLISHMENT NURSE CALL SYSTEM DOES NOT DISCRIMINATE THE PRIORITY OF SIGNAL BETWEEN THE CALLING BELL AND THE DETECTION SYSTEM; THE BED EXIT ALARM WAS TAKEN AS CALL BELL AND THE BED EXITING RESULTED IN A FALL. THERE WERE NO CONSEQUENCE REQUIRING A MEDICAL INTERVENTION FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914316 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC FL36 00670482000067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other