BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3823277 · Received February 27, 2014

    Report

    Report Number
    1824206-2014-00643
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICAL SUPPORT REPRESENTATIVE PERFORMED TROUBLESHOOTING OVER THE PHONE WITH THE ACCOUNT, AND THE ACCOUNT IDENTIFIED THAT THE SHEAVES WERE MISSING. THE HILL-ROM TECHNICAL SUPPORT REP ADVISED THE CUSTOMERS TO REPLACE THE MISSING SHAVES. 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 2007-2010. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. HILL-ROM TECHNICAL SUPPORT CONTACTED THE CUSTOMER TWO ADDITIONAL TIMES TRYING TO OBTAIN THE RESOLUTION FOR THIS ALLEGED ISSUE. NO RESPONSE HAS BEEN RECEIVED FROM THE ACCOUNT. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM TECHNICAL SUPPORT RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED 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
    122586 ADVANCE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1105

    Patients

    Seq Age Sex Outcome Treatment
    1