BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVNATA BED

    MDR report key: 3821259 · Received April 28, 2014

    Report

    Report Number
    1824206-2014-01318
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE BRAKES NOT HOLDING. PER THE HILL-ROM SERVICE MANUAL THE ADVANTA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE MODE. TEST THE STEER MODE TO DETERMINE IF THE FOOT AND CASTERS LOCK IN THE STEER MODE. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED FROM 2006 TO 2011 AND 2013 TO 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE BRAKE LINKAGE, SCREWS AND CROSS SHAFT 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 BRAKES WERE NO HOLDING. THE BED WAS LOCATED IN THE BED SHOP AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254458 ADVNATA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1