BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPO2RT

    MDR report key: 6099463 · Received November 14, 2016

    Report

    Report Number
    6099463
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 8, 2016
    Manufacturer
    HILL-ROM, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEAD OF BED (HOB) IN WALL DID NOT REMAIN ELEVATED TO 30 DEGREES, IT IS SLOWLY LOWERING. HOB MUST BE MAINTAINED AT 30 DEGREES IN ORDER TO MEET VENTILATOR BUNDLE ELEMENTS TO PREVENT VAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752042 TOTALCARE SPO2RT BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM, INC. P1900E005297

    Patients

    Seq Age Sex Outcome Treatment
    1