BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED, HOSPITAL MANUAL

    MDR report key: 891858 · Received August 8, 2007

    Report

    Report Number
    2182305-2007-00030
    Event Type
    Death
    Date Received
    August 8, 2007
    Date of Event
    July 29, 2005
    Report Date
    May 10, 2007
    Manufacturer
    OPTIMA HEALTHCARE, INC
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR OF AN ENTRAPMENT DEATH ALLEGEDLY WITH A BED MANUFACTURED BY OPTIMA HEALTHCARE INC. FIRST NOTICE OF LAWSUIT BY COUNSEL FOR THE FAMILY WAS SERVED IN 2007. "IT STATED THE DECEASED SLEPT ON THE SUBJECT BED AND IN 2005 WAS FOUND ENTRAPPED BETWEEN THE RAILS AND THE MATTRESS, DEATH WAS STATED AS ASPHYXIA DUE TO NECK COMPRESSION, PER THE SUMMONS". THE HOME HOSPITAL BED WAS PRESCRIBED BY THE DOCTOR, BUT THE PRESCRIPTION DID NOT DESIGNATE A BED TYPE. THE PT'S HUSBAND SELECTED THE BED FROM A MEDICAL SUPPLY COMPANY. BED MODEL SELECTED IS AS FOLLOWS: OPTIMA IC-5307 MANUAL SINGLE CRANK HI/LOW, FOR USE WITH IC-5000 HEAD SECTION, IC-5770 FOOT SECTION, IC-5301 BED END SET, AND IC-6629 FULL LENGTH TELESCOPING RAILS. THERE WERE TWO MATTRESSES ON THE BED AT TIME OF INCIDENT, THE LOWER MATTRESS WAS A THERAPEUTIC FOAM MANUFACTURED FOR SUBJECT BED. THE SECOND MATTRESS ON THE BED WAS AN INFLATABLE ALTERNATING AIR SUPPLY MATTRESS NOT MANUFACTURED BY THE BED MANUFACTURER. THIS REPORT IS STILL IN THE DISCOVERY STAGE. THERE IS AN INSPECTION OF SUBJECT BED SCHEDULED FOR SOMETIMES IN AUGUST. IS BELIEVED TO BE A ZONE 3; BETWEEN THE RAIL & MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, HOSPITAL MANUAL BED, MANUAL FNJ OPTIMA HEALTHCARE, INC IC-5307

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death