BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUEEN'S PRIDE 600LM CONVERTIBLE

    MDR report key: 522190 · Received April 22, 2004

    Report

    Report Number
    522190
    Event Type
    Injury
    Date Received
    April 22, 2004
    Date of Event
    April 16, 2004
    Report Date
    April 20, 2004
    Manufacturer
    BIG BOYZ INDUSTRIES, INC
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/23/2004: MFR AS NOT FIRST PARTY TO THE EVENT. THE FOLLOWING INFO WAS GIVEN TO MFR BY THE MEDICAL EQUIPMENT DEALER (WHO RENTED THE BED TO THE FACILITY), AND THE FACILITY ADMINISTRATOR. MFR WAS TOLD AT THE TIME OF THE EVENT THE PT (WEIGHING APPROXIMATELY 365 LBS.) HAD BEEN ROLLED OVER TO THEIR SIDE BY NURSING PERSONNEL, PLACING THEM AT THE EDGE OF THE BED AGAINST THE SIDE RAIL. IN ORDER TO MAINTAIN THIS POSITION, THE PT HAD TO CLING TO THE RAIL BY PLACING THEIR WEIGHT AND HANDS ON TOP OF THE RAIL. PLEASE NOTE, FOR PT SAFETY A NURSE SHOULD HAVE BEEN POSITIONED TO STABILIZE THE PT. THE BED WAS NOT RETURNED TO MFR FOR ASSESSMENT, PART REPAIR OR REPLACEMENT. THEREFORE, WE ARE UNABLE TO DETERMINE IF THERE WAS SIDE RAIL MALFUNCTION OR IF SIDE RAIL FAILED DUE TO IMPROPER USE.

    Description of Event or Problem · 1

    PT WAS IN A "BIG BOY" BARIATRIC BED. THE PT WAS LEANING AGAINST THE SIDE RAIL WHEN IT BROKE OFF THE BED. PT FELL TO FLOOR FRACTURING THEIR FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEEN'S PRIDE 600LM CONVERTIBLE BARIATRIC BED FNL BIG BOYZ INDUSTRIES, INC QP3948 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization