BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANTA, ADVANTA FRAME

    MDR report key: 1695910 · Received May 18, 2010

    Report

    Report Number
    1824206-2010-07348
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICIAN STATED THAT RISK MANAGEMENT WOULD NOT RELEASE ANY INFORMATION REGARDING THE ALLEGED PATIENT FALL. THE ACCOUNT ALLEGED THAT BED EXIT WAS SET AND THE PATIENT TRIED TO EXIT THE BED AND THE ALARM DID NOT ACTIVATE. TECHNICIAN INSPECTED THE BED AND FOUND THE SCALE AND BED EXIT TO BE OPERATING CORRECTLY.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED A PATIENT FALL, ALLEGING THE PPM FAILED TO ALARM. ACCOUNT STATED THE SCALE WAS READING -(B)(6). THE BED WAS FOUND IN PATIENT ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA, ADVANTA FRAME MED SURGICAL FNL HILL-ROM INC. P1600B005348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK