BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTA BED

    MDR report key: 2521390 · Received April 3, 2012

    Report

    Report Number
    1824206-2012-01869
    Event Type
    Death
    Date Received
    April 3, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 16, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH TESTED THE BED AND FOUND ALL BED EXITING MODES WOULD SET AND ALARM WHEN WEIGHT WAS REMOVED FROM THE BED. THE TECH AND THE ACCOUNTS ENGINEERING DEPARTMENT COULD NOT DUPLICATED THE ALLEGED MALFUNCTION. A MODEL 1600 ADVANTA BED USER MANUAL CONTAINS DETAILED INSTRUCTIONS ON PROPERLY SETTING THE PT POSITION MONITOR. THE PT POSITION MONITOR IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. IT MUST BE USED IN CONJUNCTION WITH SOUND PT RISK ASSESSMENT AND PROTOCOL TO PREVENT PERSONAL INJURY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE NIGHT ATTENDANT FINISHED WORKING WITH THE PT, PLACED HER IN THE BED, SET THE END EXIT. AUDIBLE BEEPS WERE HEARD WHEN SETTING THE BED EXIT. THE NURSE RETURNED ABOUT AN HOUR LATER AND NOTICED THE PT WAS NOT IN BED AND FOUND HER SITTING ON THE FLOOR ON THE OPPOSITE SIDE OF THE BED. THE NURSE NEVER HEARD THE BED EXIT ALARM GO OFF, BUT AT THE TIME OF THE INCIDENT, SHE WAS WORKING WITH ANOTHER PT AND COULD NOT SAY IF SHE NOTICED IF THE BED EXIT ALARM WAS ON AND/OR SET. THE PT EXPIRED. THE ACCOUNT INDICATED THE PT DEATH WAS UNRELATED TO THE BED. A DNR WAS IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death