BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3022145 · Received March 26, 2013

    Report

    Report Number
    1525712-2013-02304
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVERSE EVENT ALLEGED. MALFUNCTION ALLEGED. END USER STATES THE HEAD OF THE BED HAS BEEN LEANING TO THE LEFT. SHE STATES THAT THE LEANING OF THE HEAD OF THE BED CAUSED HER TO FALL OUT OF THE BED IN OCTOBER. SHE ALSO STATES THAT THE FALL CAUSED BRUISING ON THE BACK OF HER RIGHT LEG AND ON HER ARMS. SHE SAYS SHE IS NOT REQUIRED TO USE THE BED RAILS ON THE SIDE OF THE BED WHILE IN IT. SHE STATES THAT THE BED RAIL ON THE LEFT SIDE WILL NOT GO UP SINCE THE BED IS LEANING. END USER STATES THAT ONCE WEIGHT IS PUT ON THE HEAD OF THE BED IT SLOWLY LOWERS ALL THE WAY DOWN. SEE ALSO ORACLE REFERENCE NUMBERS (B)(4). NO MEDICAL INTERVENTION WAS SOUGHT. MDR FILED.

    Description of Event or Problem · 1

    (B)(4). ADVERSE EVENT ALLEGED. MALFUNCTION ALLEGED. END USER STATES THE HEAD OF THE BED HAS BEEN LEANING TO THE LEFT. SHE STATES THIS CAUSED HER TO FALL OUT OF THE BED, CAUSING BRUISING ON HER RIGHT LEG AND ARMS. NO MEDICAL INTERVENTION WAS SOUGHT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124742 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 Other