BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1163377 · Received September 10, 2008

    Report

    Report Number
    1824206-2008-03362
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HILL-ROM TECHNICAL SUPPORT REP RECOMMENDED TO CHANGE THE SCALE BOARD, TO RESOLVE THE PROBLEM WITH THE PPM.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE PPM IS TURNING OFF INADVERTENTLY. CUSTOMER ALLEGED THAT THE NURSE HAS TO RE-ARM THE PPM AFTER IT SHUTS OFF. THERE WERE NO REPORTED INJURIES. PURSUANT TO OUR RESPONSE TO WARNING LETTER, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 93200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1