BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED BED

    MDR report key: 3830223 · Received May 12, 2014

    Report

    Report Number
    1824206-2014-01460
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE HEAD RIGHT BRAKE CASTER WAS OUT OF ADJUSTMENT MOST LIKELY DUE TO NORMAL WEAR AND TEAR. PER THE HILL-ROM SERVICE MANUAL THE RETRACTABLE BED MUST HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM PREVENTATIVE MAINTENANCE ANNUALLY TO HELP TO ENSURE A LONG AND PRODUCTIVE LIFE FOR THE RETRACTABLE BED. THIS WILL HELP MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR FAILURES. BRAKE AND STEER: TEST THE BRAKES TO DETERMINE IF THE BED MOVES WHEN THE BRAKE IS ACTIVATED. ADJUST IF REQUIRED. INSPECT THE STEER ACTIVATION AND ADJUST IF REQUIRED. CHECK CASTER TIRES FOR CUTS, WEAR, TREAD, ETC. REPLACE IF NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN ADJUSTED THE HEAD RIGHT BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN FOUND A NOTE ON THE BED THAT STATED IT WAS BROKEN. THE TECHNICIAN FOUND THE HEAD RIGHT BRAKE CASTER WHEEL DID NOT HOLD WHEN THE BRAKE PEDAL WAS SET. THE BED WAS LOCATED IN MED SURGE AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283301 REMANUFACTURED BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 8200

    Patients

    Seq Age Sex Outcome Treatment
    1