BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1120092 · Received August 15, 2008

    Report

    Report Number
    1824206-2008-03109
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008 - REPORTER ALLEGED THE HEAD FRAME WAS BENT/DAMAGED. NO INJURY REPORTED. HE DOES NOT KNOW HOW IT WAS BENT. A WEEK LATER - TECH - HEAD SECTION DAMAGED. REPLACED HEAD SECTION WELDMONT, BOTH LEFT AND RIGHT RETRACTING ARMS AND BOTH PIVOT EXTRUSION SLIDES. REPLACED HEAD CYLINDER, D-PIN, AND LONG SENSOR LINK. APPLIED APPROPRIATE LABELS. REPAIR COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900M006949

    Patients

    Seq Age Sex Outcome Treatment
    1