BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2231316 · Received July 26, 2011

    Report

    Report Number
    8020711-2011-00009
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS UK LTD.
    Product Code
    KPQ
    PMA / PMN Number
    K023052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED DUE TO A CBCT SECOND RECONSTRUCTION PROBLEM. AFTER PERFORMING A CBCT TRIPLE SCAN, THE RECONSTRUCTION DISPLAYED IMAGES ARE SHORTER, AS COMPARED TO THE FIRST RECONSTRUCTED IMAGE; SPECIFICALLY, THE BOTTOM OR LOWER-HALF PORTION OF THE SECOND RECONSTRUCTED IMAGES IS MISSING. NO ERROR MESSAGE IS DISPLAYED. THERE WAS NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY ACCELERATOR, LINEAR, MEDICAL KPQ VARIAN MEDICAL SYSTEMS UK LTD. H77

    Patients

    Seq Age Sex Outcome Treatment
    1