BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA II

    MDR report key: 2243938 · Received September 2, 2011

    Report

    Report Number
    3006697241-2011-00099
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE MOUNTING HOLES IN THE PLASTIC SIDERAIL WERE STRIPPED WHERE THE SCREWS SECURE THE SIDERAIL IN PLACE TO THE SIDERAIL ARM, CAUSING THE SIDERAIL TO BREAK OFF. THE TECH REPLACED THE SIDERAIL AND SCREWS TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE LEFT FOOT SIDERAIL HAS BROKEN AWAY FROM THE SIDERAIL ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA II AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1