BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPORT BED

    MDR report key: 3844822 · Received March 12, 2014

    Report

    Report Number
    1824206-2014-00832
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HEAD END BRAKE CASTERS WERE BROKEN (THE PARTS AT THE HOLE WHERE THE HEX SHAFT CONNECTS). PER THE HILL-ROM SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AND EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE BRAKE CASTER TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE, REPLACE OR ADJUST WHEN NECESSARY. CHECK THE TIRES FOR CUTS, WEAR, TREAT LIFE, ETC. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FORM A HILL-ROM TECHNICIAN STATING THE HEAD END BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN A HILL-ROM SERVICE CENTER AND NOT IN USE. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149147 TOTALCARE SPORT BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1