BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOERNS (HEALTHCARE INC.)

    MDR report key: 512408 · Received February 9, 2004

    Report

    Report Number
    512408
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    January 14, 2004
    Report Date
    January 20, 2004
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS ASPHIXIATED BY A SIDERAIL ON THEIR BED. THEY WERE FOUND WITH THEIR HEAD CAUGHT BETWEEN THE MIDDLE AND LOWER RUNG OF A HALF SIDE-RAIL. THEIR FEET WERE ON THE FLOOR. THEY HAD BEEN POSITIONED IN THE BED ON THEIR LEFT SIDE AND HAD BEEN OBSERVED TO BE SLEEPING APPROX. 45 MINUTES PRIOR TO WHEN THEY WERE FOUND. THEY HAD AN AIR MATTRESS ON THEIR BED. IT APPEARED THAT THEY TURNED OVER AND FELL FROM THE BED GETTING THEIR HEAD CAUGHT IN THE SIDE RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOERNS (HEALTHCARE INC.) BED HALF-LENGTH SIDERAIL FNJ SUNRISE MEDICAL B40, B41, B50 *
    2 JOERNS (HEALTHCARE INC.) BED HALF-LENGTH SIDERAIL FNJ SUNRISE MEDICAL B40, B41, B50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death