BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA BED

    MDR report key: 3810294 · Received April 10, 2014

    Report

    Report Number
    1824206-2014-01132
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 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 TECH FOUND THE BRAKE CASTER WAS OUT OF ADJUSTMENT. THE MOST LIKELY CAUSE WAS NORMAL WEAR AND TEAR. PER THE PM RECORDS, THE LAST TIME THE BRAKE CASTERS WERE REPLACED WAS 2009. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009 THROUGH 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH ADJUSTED THE BRAKE CASTER AND THE BED FUNCTIONED AS DESIGNED. THERE WERE NO REPORTED INJURIES. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY.

    Description of Event or Problem · 1

    THE TECH WAS PERFORMING PREVENTATIVE MAINTENANCE AND REPORTED THE BRAKE WOULD NOT HOLD WHEN THE BRAKE PEDAL WAS SET TO THE BRAKE POSITION. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY. 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
    216652 CENTRA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 850

    Patients

    Seq Age Sex Outcome Treatment
    1