BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1181930 · Received September 26, 2008

    Report

    Report Number
    1824206-2008-03602
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT. TSR FOUND BED WOULD NOT WORK. NO INJURY REPORTED. REPLACED POWER PCB BOARD TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900E005122

    Patients

    Seq Age Sex Outcome Treatment
    1