BEUDAMED
    FDA Adverse Event Summary report: N

    HOSPITAL BED

    MDR report key: 1842696 · Received September 16, 2010

    Report

    Report Number
    2182305-2010-00033
    Date Received
    September 16, 2010
    Date of Event
    December 30, 2009
    Report Date
    August 20, 2010
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, (B)(6), PER FACILITY, A MALE, PT, (B)(6) WAS PLACED IN A BARIATRIC BED WITH ALL FOUR SIDE RAILS UP. THE BED HAD A (B)(4)-AIR MATTRESS ON IT AS WELL. THE PT FELL THROUGH THE GAP BETWEEN THE TOP AND BOTTOM SIDE RAILS HITTING HIS HEAD ON THE FLOOR. [AS DESCRIBED THIS WOULD BE A ZONE 5; BETWEEN SPLIT BED RAILS]. HE WAS SENT TO THE HOSPITAL FOR A CT SCAN WHICH REVEALED AN INCREASE IS SOFT TISSUE SWELLING. HE REQUIRES A HIGHER LEVEL OF CARE SINCE. PER MANUFACTURER, NO RA ISSUED BECAUSE BED IS NOT IN QUESTION; HOWEVER, THE MANNER IN WHICH IT WAS USED WAS INAPPROPRIATE. A PT OF THIS SMALL STATURE/(B)(6) SHOULD NOT HAVE BEEN PLACED ON A BARIATRIC BED - THIS IS BEING FILED AS "WAS NOT USED AS MANUFACTURER SPECIFIED". MANUFACTURER ALSO REFERENCED (B)(4) EXCLUSION FROM THE SCOPE OF THEIR GUIDANCE WHICH INCLUDES BARIATRIC BEDS TO THE FACILITY. COPY OF MEDWATCH FORM RECEIVED BY FACILITY, DATE OF EVENT WAS (B)(6) 2009, HOWEVER, MANUFACTURER FIRST NOTIFIED ON JULY 25, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL BED HOSPITAL BED, ELECTRIC FNL JOERNS HEALTHCARE BARI10-A BED

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization