BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 4121820 · Received July 28, 2014

    Report

    Report Number
    1824206-2014-02037
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K962942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN INVESTIGATED AND FOUND THE LEFT INTERMEDIATE SIDE RAIL FUNCTIONED AS DESIGNED. NO REPAIR WAS NEEDED. LARRY DID STATE THE ACCOUNTS MAINTENANCE STATED THERE WAS NO INJURY FROM THE PATIENT FALL AND THERE MAY HAVE BEEN A SHEET CAUGHT IN THE SIDE RAIL LATCH AT THE TIME OF THE INCIDENT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2007 THROUGH 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. NO REPAIR NEEDED THE LEFT INTERMEDIATE SIDE RAIL WAS FOUND TO FUNCTION AS DESIGNED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNTS MAINTENANCE REPORTED A PATIENT FELL OUT OF THE BED WHILE THE NURSING STAFF WAS TURNING THE PATIENT TO THE LEFT SIDE OF THE BED. THE ACCOUNT STATED THE LEFT INTERMEDIATE SIDE RAIL DROPPED DOWN CAUSING THE PATIENT TO FALL TO THE FLOOR. THE BED WAS LOCATED IN ICU AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439896 TOTALCARE BED A/C POWERED ADJUSTABLE HOSP. BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1