BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2

    MDR report key: 2670967 · Received July 19, 2012

    Report

    Report Number
    3006697241-2012-00166
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    June 26, 2012
    Report Date
    June 26, 2012
    Manufacturer
    HLL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Removal / Correction Number
    1824206-05/16/2012-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO FOUND THE SCREWS HOLDING THE SIDERAIL IN PLACE WERE STRIPPED OUT. HE REPLACED THE SIDERAIL AND CONTROL PANELS TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE RIGHT HEAD SIDERAIL FELL OFF OF THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA 2 AC-POWERED ADJUSTABLE HOSPITAL BED FNL HLL-ROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1