BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3843730 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00404
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE RIGHT HEAD BRAKE CASTER IS THE CAUSE. PER THE HILL-ROM SERVICE MANUAL THE ADVANCE SERIES BED REQUIRES EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE MODE, REPLACE OR ADJUST WHEN NECESSARY. THE TECHNICIAN REPLACED THE RIGHT HEAD BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE BRAKE SET BUT WILL NOT HOLD AT THE HEAD END OF THE BED. THE BED IS LOCATED IN THE BED SHOP OF THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92656 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1135

    Patients

    Seq Age Sex Outcome Treatment
    1