BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 2050497 · Received April 5, 2011

    Report

    Report Number
    1824206-2011-02006
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN SUGGESTED THAT THE ACCOUNT REPLACE THE BED EXIT SENSORS. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BED EXIT ONLY ALARMS ON OUT OF THE BED. FOR POSITIONING AND EXITING THE BED EXIT WILL ARM, BUT NOT ALARM. NO INCIDENT WAS REPORTED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1