BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BED

    MDR report key: 1243264 · Received November 7, 2008

    Report

    Report Number
    1243264
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 7, 2008
    Manufacturer
    HILL-ROM COMPANY, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ENTERING PATIENT'S ROOM, NURSE FOUND PATIENT OUT OF BED, LAYING NEXT TO BED ON THE FLOOR. THE BED EXIT ALARM WAS IN USE, WITH THE ALARM DELAY SET AT 2 SECONDS. UPON ENTERING THE ROOM, NURSE FOUND THAT THE SOUND OF THE ALARM WAS AT A VOLUME LEVEL THAT WAS LOWER THAN NORMAL FUNCTIONING. IN ADDITION, THE SOUND OF THE ALARM WAS A DIFFERENT SOUND THAN THAT ASSOCIATED WITH NORMAL FUNCTIONING. AT A POINT OUTSIDE OF THE PATIENT'S ROOM WHERE THE ALARM SOUND WOULD NORMALLY HAVE BEEN HEARD, THE ALARM SOUND WAS NOT AUDIBLE.====================== MANUFACTURER RESPONSE FOR PATIENT BED, TOTAL CARE BED======================HILL ROM TECHNICIAN LOOKED AT ALARM. STATED "TESTED BED ALARM. INITIAL SOUND WAS NOT THE USUAL SOUND OF THE ALARM. IT WAS A SOFTER SOUND, ALMOST A VIBRATION. THIS LASTED FOR 3 SECONDS OR SO, THEN THE SOUND BECAME LOUDER." ORDERED REPAIR ON BED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CARE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM COMPANY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *