BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY BED

    MDR report key: 3843758 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00384
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, THE TECHNICIAN FOUND THAT A PREVIOUS SERVICING COMPANY HAD REPLACED A ROLL PIN WITH A WIRE AND TWO SCREWS ON A PREVIOUS REPAIR. PER THE HILL-ROM SERVICE MANUAL THE CENTURY BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM ANNUAL PREVENTATIVE MAINTENANCE. ENSURE THE BED DOES NOT MOVE WHEN THE BRAKES ARE ACTIVATED. ADJUST THE BRAKES IF NECESSARY. INSPECT AND ADJUST THE STEERING MECHANISM IF NECESSARY. CHECK THE CASTER TIRES FOR CUTS, WEAR, TREAT, ETC. REPLACE IF NECESSARY. THE DEVICE REFERENCED IN THIS REPORT IS OVER 12 MONTHS OLD AND ACCORDING TO THE RECOMMENDED PREVENTIVE MAINTENANCE SCHEDULE AT LEAST ONE PM SHOULD BE PERFORMED EVERY 12 MONTHS. THEREFORE, THE ACCEPTANCE CRITERIA, BASED ON THE DHR, WERE DETERMINED TO BE ACCEPTABLE AT THE TIME THE DEVICE WAS RELEASED. GIVEN THE TIME WHICH HAS ELAPSED, THE ALLEGED FAILURE OF THE DEVICE WOULD NOT BE RELATED TO ANY ISSUE WHICH OCCURRED DURING THE MFG PROCESS. THE TECHNICIAN REPLACED THE ROLL PIN TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT WHEN THE FOOT END BRAKE PEDAL IS SET TO BRAKE MODE THE BRAKE CASTERS DO NOT HOLD. THE BED WAS LOCATED IN THE PARKING GARAGE OF 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
    92821 CENTURY BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1400

    Patients

    Seq Age Sex Outcome Treatment
    1