BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED, HOSPITAL

    MDR report key: 1674573 · Received April 22, 2010

    Report

    Report Number
    2182305-2010-00012
    Event Type
    Other
    Date Received
    April 22, 2010
    Date of Event
    March 27, 2010
    Report Date
    April 21, 2010
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, (B)(6), PER FACILITY THEY WERE PREPARING FOR NEW ADMISSION, NEW RESIDENT WAS COMING FROM THE HOSPITAL. UPON ARRIVAL THE BED WAS RAISED APPROXIMATELY 30 INCHES, FOR PROPER TRANSFER FROM A GURNEY, AIDED BY THE AMBULANCE CREW. AFTER RESIDENT WAS TRANSFERRED, THE NURSING STAFF RAISED THE HEAD OF BED AND PROCEEDED TO LOWER THE ENTIRE BED. AT THIS POINT, THE HEAD END LEVELING MECHANISM FAILED, ALLOWING THE HEAD OF THE BED TO FALL TO ITS LOWEST POSITION. UPON CLOSE EXAMINATION BY FACILITY, IT WAS EVIDENT THAT THE HEAD LEVELING MECHANISM PIN HAD A BROKEN COTTER PIN WHICH ALLOWED THE PIN TO SLOWLY LOOSEN AND FINALLY FALL OUT. THIS COTTER PIN FAILURE ALLOWED THE HEAD LEVELING MECHANISM TO DETACH FROM THE FRAME AND LOOSE THE ABILITY TO SUPPORT THE HEAD OF THE BED. FAMILY MEMBERS WERE THERE AND TOOK PICTURES - STATING THAT THEY ARE VERY CONCERN OVER THIS FAILURE BEING A SAFETY ISSUE. FACILITY CEO TOOK BED OUT OF SERVICE. PICTURES WERE SENT BY FACILITY TO REVIEW, IN ADDITION MANUFACTURER TRYING TO GET BED BACK FOR EVALUATION. FACILITY RISK MANAGER STATED SHE WILL HAVE TO GET PERMISSION FROM THE CEO TO HAVE BED RETURNED TO US. (B)(4) UNDER COMPLAINT (B)(4) WAS ISSUED TO GET PRODUCT BACK FOR IN-HOUSE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, HOSPITAL BED, HOSPITAL, ELECTRIC FNL JOERNS HEALTHCARE, INC. U770AL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other