BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED, HOSPITAL ELECTRIC

    MDR report key: 891854 · Received August 8, 2007

    Report

    Report Number
    2182305-2007-00031
    Event Type
    Death
    Date Received
    August 8, 2007
    Date of Event
    January 7, 2007
    Report Date
    August 6, 2007
    Manufacturer
    OPTIMA HEALTHCARE, INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR OF A DEATH INVOLVING A BED MANUFACTURED BY OPTIMA HEALTHCARE INC. NOTICE OF WRONGFUL DEATH CLAIM BY COUNSEL FOR FAMILY WAS SERVED IN 2007. PER CLAIM, HOME USER WAS HAVING PROBLEM WITH A BED SHE LEASED/PURCHASED FROM DEALER . SHE COULD NOT GET THE CONTROLLER TO WORK AS IT SHOULD. ON THE DAY OF THE INCIDENT, "IT IS BEING ALLEGED THAT THE BED MALFUNCTIONED WHEN END-USER'S DAUGHTER PLUGGED IT INTO WALL SOCKET. BED ALLEGEDLY RETRACTED TRAPPING DAUGHTER BETWEEN HEAD BOARD AND FRAME CRUSHING HER STERNUM WHICH RESULTED IN DEATH". PARAMEDICS TOOK NUMEROUS PICTURES AND AN AUTOPSY WAS PERFORMED. THIS REPORT IS STILL IN THE DISCOVERY STAGE. THERE IS AN INSPECTION OF SUBJECT BED SCHEDULED FOR SOMETIME IN AUGUST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death