BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR ADVANCED BED

    MDR report key: 3830123 · Received May 8, 2014

    Report

    Report Number
    1824206-2014-01429
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH FOUND SCREW HOLDING THE CABLE BROKE OFF IN THE TOP BLOCK CAUSING THE BRAKE NOT TO HOLD. 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 TIRED 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 2007-2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE HILL-ROM TECH REPLACED THE BLOCK AND SCREW TO RESOLE 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 ARE NOT ENGAGING WHEN THE PEDAL IS PRESSED (BRAKES NOT HOLDING). THE BED WAS LOCATED AT THE ACCOUNT IN DIALYSES. 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
    278193 MOTOR ADVANCED BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1130

    Patients

    Seq Age Sex Outcome Treatment
    1