BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3810375 · Received April 11, 2014

    Report

    Report Number
    1824206-2014-01152
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HEAD BRAKE CASTER NOT HOLDING DUE TO THE WHEEL BEING CRACKED. 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. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2010. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE HEAD BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE HEAD BRAKE CASTER IS NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN THE BED SHOP. 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
    221616 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1155

    Patients

    Seq Age Sex Outcome Treatment
    1