BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRAL AXIS MARKER

    MDR report key: 1461400 · Received August 31, 2009

    Report

    Report Number
    1932738-2009-00002
    Event Type
    Other
    Date Received
    August 31, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 28, 2009
    Manufacturer
    MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS)
    Product Code
    IWE
    PMA / PMN Number
    K951601
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER AND CIVCO MEDICAL ENGINEER REVIEWED THE SITUATION VIA PHONE. DEVICE IS DELIVERED TO CUSTOMER UNCODED, MEANING THAT THE LINAC DOSE NOT KNOW IT IS IN PLACE WHEN IT IS INSERTED INTO THE HEAD/WEDGE MOUNT ASSEMBLY. MANUFACTURER RECOMMENDS THAT THEY SHOULD CODE IT (FILL IN THE APPROPRIATE HOLES TO MATCH THEIR BB TRAY). THIS WAY THE SYSTEM WILL LET THEM IMAGE WITH IT IN, BUT NOT TREAT - IT WILL CAUSE AN INTERLOCK AND PREVENT THEM FROM TREATING UNTIL THEY PULL THE TRAY. CONCLUSION: USER ERROR CAUSED EVENT AS DEVICE WAS NOT REMOVED PRIOR TO TREATMENT. DEVICE WAS NOT CODED PRIOR TO USE WHICH PREVENTS TREATING WITH THE TRAY IN PLACE AND THIS CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THERAPIST INTERRUPTED AFTER INITIAL SETUP AND THE DEVICE (CENTRAL AXIS MARKER) WAS LEFT IN THE WEDGE MOUNT ASSEMBLY. WHEN TREATING THERE WAS NO ACCESSORY INTERLOCK CODED ON DEVICE (CENTRAL AXIS MARKER) IN THE LINAC. TREATED PATIENT WITH THE DEVICE (CENTRAL AXIS MARKER) STILL IN PLACE. MEASUREMENTS OF THE ATTENUATION OF THE POLYCARBONATE MATERIAL OF THE DEVICE (CENTRAL AXIS MARKER) SHOWED AN UNDERDOSE OF 5% IN THE TREATMENT VOLUME BEYOND THE 5X5CM. NO CORRECTION FOR UNDERDOSE WAS REQUIRED/ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL AXIS MARKER CENTRAL AXIS MARKER IWE MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other