BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE

    MDR report key: 1851978 · Received September 24, 2010

    Report

    Report Number
    1824206-2010-10106
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT INSPECTED THE EMERGENCY TRENDELENBURG VALVE AND IT SEEMED TO BE DAMAGED. TECHNICAL SUPPORT TOLD ACCOUNT THAT THEY CAN SWAP IT WITH THE CARDIO PULMONARY RESUSCITATION VALVE AND SEE WHERE THE ISSUE FOLLOWS. NO FURTHER INFO IS AVAILABLE ON THE REPAIR.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE HEAD HI/LOW IS DRIFTING DOWN. THERE WERE NO REPORTS OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CARE NONE FNL HILL-ROM INC. PR1900

    Patients

    Seq Age Sex Outcome Treatment
    1