BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA BED

    MDR report key: 3843712 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00386
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, TECHNICIAN FOUND THE CASTERS ON THE DEVICE WERE WORN WITH WEAR AND TEAR ASSOCIATED WITH AGE. THE CASTERS ON THE DEVICE HAVE BEEN IN SERVICE SINCE 1991 AND THERE IS NO RECORD OF THE CASTERS BEING REPLACED BEFORE THIS INCIDENT. 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 MANUFACTURING PROCESS. THE TECHNICIAN REPLACED THE BRAKE CASTERS, BRAKE STEER CASTER AND THE BRAKE MECHANISM ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED HE FOUND THE BED VACANT AND IT HAD A NOTE ON IT STATING THE BRAKES ARE NOT FUNCTIONING. THE BED WAS LOCATED IN THE BASEMENT OF THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. HIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93341 CENTRA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 852

    Patients

    Seq Age Sex Outcome Treatment
    1