BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSPITAL BED ELECTRIC

    MDR report key: 627037 · Received August 11, 2005

    Report

    Report Number
    2182305-2005-00016
    Event Type
    Death
    Date Received
    August 11, 2005
    Date of Event
    July 21, 2002
    Report Date
    August 1, 2005
    Manufacturer
    OPTIMA HEALTHCARE, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THROUGH DEALER, PER A CLAIMS ADJUSTER ON FILE AND THEIR ATTY, REPORTED AS AN END USER DEATH, DATE 2002 DESCRIPTION. PT FELL BETWEEN MATTRESS AND RAILING/FRAME. PT BECAME TRAPPED AND DIED. THEY DON'T KNOW WHAT RAILS OR MATTRESS WERE USED ON THE BED AT THIS TIME, WAITING FOR OPPORTUNITY TO INSPECT THE PRODUCT. YET TO BE DETERMINED, BED WAS REPORTED TO BE AN OPTIMA 5310 SEMI ELECTRIC. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL BED ELECTRIC ELECTRIC BED FNL OPTIMA HEALTHCARE, INC. IC-5310 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death