BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE PULMONARY SURFACE

    MDR report key: 1851320 · Received September 23, 2010

    Report

    Report Number
    1824206-2010-10081
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT STATED THEY REPLACED THE HEAD DOWN VALVE AND THAT RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    ACCOUNT ALLEGES THE HEAD HI/LOW WILL SLOWLY DRIFT DOWN OVER NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE PULMONARY SURFACE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1900

    Patients

    Seq Age Sex Outcome Treatment
    1