BEUDAMED
    FDA Adverse Event Death Summary report: N

    MANUAL HOSPITAL BED W/ SIDE RAIL

    MDR report key: 2655048 · Received July 5, 2012

    Report

    Report Number
    2182305-2012-00024
    Event Type
    Death
    Date Received
    July 5, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 22, 2012
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR SALES REP BY FACILITY, FACILITY STATES A RESIDENT WAS IN BED AND WAS TRYING TO GET OUT OF BED SUPPORTED BY A SIDE RAIL WHEN THE RETAINING CLIP BROKE ON THE FULL LENGTH SIDE RAIL [F16] AND SHE FELL TO THE FLOOR. RESIDENT WAS FOUND ON THE FLOOR LYING ON TOP OF THE SIDE RAIL. THE RESIDENT WAS TAKEN TO THE HOSPITAL, SCAN WAS DONE WHICH REVEALED RESIDENT SUSTAINED A BROKEN HIP, THE HOSPITAL DETERMINED SHE WAS TOO FRAIL TO RECEIVE ANESTHESIA; NO SURGERY WAS PERFORMED AND SHE PASSED AWAY IN THE HOSPITAL THEREAFTER. PER THE SALES REP, "WHEN HE SPOKE WITH THE C.N.A. AND (B)(6) THEY SUPPORT THAT THIS RESIDENT IS A FALL RISK, WANDERS, AND HAS A HISTORY OF CLOSE CALL FALLS." WHEN DEALING WITH THIS CALL, THE FACILITY INFORMED US THAT THEY HAD AN EARLIER SIMILAR INCIDENT WITH A DIFFERENT RESIDENT WHICH WILL BE REPORTED UNDER SEPARATE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL HOSPITAL BED W/ SIDE RAIL BED W/ FULL LENGTH SIDE RAIL FNJ JOERNS HEALTHCARE B784 W/ F16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death