BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA BED

    MDR report key: 3811101 · Received April 17, 2014

    Report

    Report Number
    1824206-2014-01238
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BRAKES NOT HOLDING DUE TO DEFECTIVE PARTS. PER THE HILL-ROM USER MANUAL, ANNUAL PREVENTIVE MAINTENANCE MUST BE PERFORMED TO INSURE ALL BED FEATURES ARE FUNCTIONING AS ORIGINALLY DESIGNED. PARTICULAR ATTENTION MUST BE ADDRESSED ON SAFETY FEATURES, INCLUDING BUT NOT LIMITED TO CASTER BRAKING SYSTEMS. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2006,2007, AND 2009--2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED 2 BUSHINGS AND 2 CAMS ON MECHANISM BLOCK ASSEMBLY 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 BRAKE PEDAL MOVES OUT OF THE BRAKE POSITION WHEN THE BED IS MOVED (BRAKES NOT HOLDING). THE BED WAS LOCATED AT THE ACCOUNT IN THE MAINTENANCE 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
    236268 CENTRA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 850

    Patients

    Seq Age Sex Outcome Treatment
    1