BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFPM400 TABLE

    MDR report key: 5235814 · Received November 19, 2015

    Report

    Report Number
    1000121370-2015-00002
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Report Date
    October 6, 2015
    Manufacturer
    OAKWORKS, INC
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ALLEGEDLY THE TILT ACTUATOR WOULD NOT FUNCTION. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED. THE TECHNICIAN HAD REMOVED THE TABLE FROM THE FACILITY TO EVALUATE, DIAGNOSE AND REPAIR. RESULTS FROM TROUBLESHOOTING DETERMINED THAT THE TILT ACTUATOR WAS NON-FUNCTIONAL. ACTUATOR WAS REPLACED AND THE ALLEGED NON-FUNCTIONAL ACTUATOR WAS RETURNED FOR EVALUATION. THERE WERE NO ERRORS FOUND DURING EVALUATION/TESTING AND WE WERE UNABLE TO REPLICATE THE COMPLAINT. THE TABLE WAS RETURNED TO FULL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE TECHNICIAN THAT ALLEGEDLY THE TILT ACTUATOR WAS STUCK IN A 45 DEGREE ANGLE AND WOULD NOT STRAIGHTEN OUT. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY, AND NO ADVERSE EVEN REPORTED. THE TECHNICIAN HAD REMOVED THE TABLE FROM THE FACILITY IN ORDER TO TROUBLESHOOT, DIAGNOSE AND REPAIR THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768192 CFPM400 TABLE TABLE, RADIOGRAPHIC, TILTING IXR OAKWORKS, INC 400

    Patients

    Seq Age Sex Outcome Treatment
    1