BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTA FRAME P1600

    MDR report key: 1663803 · Received April 19, 2010

    Report

    Report Number
    1824206-2010-05977
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    July 27, 2006
    Report Date
    July 27, 2006
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT MALFUNCTION; HOWEVER, SINCE THE CIRCUMSTANCES LEAD UP TO THE DEATH OF A PATIENT, THIS EVENT IS BEING REPORTED. THE ACCOUNT USED A WAIST RESTRAINT WITH THE PATIENT, AND CONNECTED IT AT THE MID-WAY POINT BETWEEN THE HEAD AND WAIST AREA OF THE BED DECK. THIS ALLOWED THE PATIENT ACCESS TO THE RESTRAINT STRAPS AND UN-TIE IT FROM THE BED. THE PATIENT THEN GOT OUT OF THE BED AND FELL AT THE DOORWAY, HITTING THEIR HEAD, AND RESULTED IN THE PATIENT'S DEATH. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT THE PATIENT FELL AS A RESULT OF LEAVING THE BED, TRYING TO LEAVE THE FACILITY. THE FALL RESULTED IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA FRAME P1600 A/C POWERED HOSPITAL BED FNL HILL-ROM RITTER P1600B005456

    Patients

    Seq Age Sex Outcome Treatment
    1 Death