BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRIT SELECT

    MDR report key: 2090000 · Received April 29, 2011

    Report

    Report Number
    3006433555-2011-00001
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    October 5, 2010
    Report Date
    April 29, 2011
    Manufacturer
    CHG HOSPITAL BEDS INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY CHECKED ALL RAILS AND REPORTED THAT THEY ALL LOCKED SECURELY IN PLACE. THE BED WAS REVIEWED BY CHG AT THE USER FACILITY AND THE BED EXIT SYSTEM WAS FOUND TO BE FUNCTIONING PROPERLY ON THE BED. NO BED MALFUNCTION. THE 37 PIN RECEIVER JACK ON THE BED WAS FOUND TO BE DAMAGED WITH BROKEN SCREWS IN THE NUTS OF THE JACK. THIS WOULD PREVENT THE NURSE CALL CABLE BETWEEN THE BED AND THE WALL FROM BEING SCREWED TO THE BED. THE 1/4" RECEIVER JACK ON THE BED WAS ALSO FOUND TO BE DAMAGED WITH THE DUMMY PLUG BROKEN OFF INSIDE. RESULTS: THE SPIRIT BED IS A LOW BED DESIGNED TO LOWER TO A MATTRESS DECK HEIGHT OF 10" OFF THE GROUND. IN THIS POSITION, THE RISK OF SERIOUS INJURY FROM A FALL IS SIGNIFICANTLY REDUCED. A WARNING IN SECTION 3.4.5 OF THE BED USER MANUAL ADDRESSES ALWAYS KEEPING THE BED IN THE LOWEST POSITION WHEN A PATIENT IS LEFT UNATTENDED. SECTION 1.9 OF THE BED USER MANUAL ADDRESSES NOT USING THE BED IF ANY COMPONENT IS DAMAGED.

    Description of Event or Problem · 1

    THE FACILITY ALLEGES THAT THE PATIENT CLIMBED OVER THE LATCHED BED SIDE RAILS, FELL AND BROKE HER HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRIT SELECT 880.5100 FNL CHG HOSPITAL BEDS INC. SPIRIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other