BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED, HOSPITAL

    MDR report key: 1240885 · Received November 10, 2008

    Report

    Report Number
    2182305-2008-00041
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, BY FACILITY, THE BOLT THAT HOLDS THE ASSIST DEVICE ON THE BED IS HELD IN PLACE BY A C-CLIP AND THIS C-CLIP HAD BROKE/OPENED UP AND DID NOT HOLD THE DEVICE ON THE BED. WHEN THE RESIDENT LEANED UP AGAINST IT, CAUSING THE ASSIST DEVICE TO SLIDE OFF THE BED, THE RESIDENT FELL OUT OF BED. RESIDENT WAS TAKEN TO THE HOSPITAL ER FOR MEDICAL EXAM BECAUSE OF BRUISING AND ABRASIONS FROM THE FALL. MFR ISSUED RMA TO GET BED ASSIST DEVICE BACK FOR EVAL. REPLACEMENT ORDER WAS ENTERED TO REPLACE DEVICE FOR CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, HOSPITAL BED, HOSPITAL, MANUAL FNJ JOERNS HEALTHCARE, INC. B684 W/F14SCAL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other