BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTALCARE CONNECT SPORT BED

    MDR report key: 3982883 · Received July 10, 2014

    Report

    Report Number
    1824206-2014-01938
    Event Type
    Other
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN INVESTIGATED AND CONDUCTED A FUNCTION TEST ON SIDE RAIL OPERATION. THE TECHNICIAN FOUND THE SIDE RAIL FUNCTIONED AS DESIGNED. A HILL-ROM REPRESENTATIVE CALLED THE ACCOUNT AND SPOKE WITH THE DIRECTOR OF QUALITY TO DISCUSS THE ALLEGATION OF A PATIENT ROTATED UP AND OVER THE SIDE RAIL. THE DIRECTOR OF QUALITY CONFIRMED THA THE BED WAS NOT IN ROTATION MODE AND DID NOT CAUSE THE PATIENT TO BE ROTATED OVER THE SIDE RAIL. THE PATIENT ROLLED OR MANEUVERED HERSELF OVER THE SIDE RAIL. THE PATIENT SUFFERED A BROKEN HIP AND REQUIRED SURGERY. THE DIRECTOR OF QUALITY AT THE ACCOUNT CONFIRMED THAT THE BED WAS FUNCTIONING AS DESIGNED ADN DID NOT CONTRIBUTE TO THE PATIENT'S FALL. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE PATIENT ROTATED AND ROLLED HERSELF OVER THE SIDE RAIL. THE BED WAS LOCATED IN ROOM 2290 AT THE FACILITY. THE PATIENT SUFFERED A BROKEN HIP AND REQUIRED SURGERY. THIS REPORT WAS FILE DIN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404880 TOTALCARE CONNECT SPORT BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization