BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC O-ARM

    MDR report key: 2201980 · Received August 3, 2011

    Report

    Report Number
    MW5021662
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ISSUE: THE MAXIMUM RADIATION DOSE RATE IN FLUOROSCOPIC MODE FOR THE MEDTRONIC O-ARM WAS GREATER THAN DEEMED SAFE BY THE MEDICAL PHYSICIST AT (B)(6). SOLUTION: AFTER MUCH DISCUSSION, THE VENDOR ACKNOWLEDGED THAT FOR UNITS SOLD IN (B)(4) THE DOSE RATE HAD TO BE DECREASED, AND AGREED TO MODIFY THE DOSE RATE ON OUR UNIT USING THE "(B)(6) SETTINGS." RESULTS: MODIFYING THE DOSE RATE TO THE "(B)(6) SETTINGS" ACHIEVED A SIGNIFICANT REDUCTION IN RADIATION EXPOSURE TO PTS. CLINICIANS REPORT NO PERCEIVED DIFFERENCE IN IMAGE QUALITY. DOSE: 60 R. FREQUENCY: MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC O-ARM O-ARM IZL MEDTRONIC NONE

    Patients

    Seq Age Sex Outcome Treatment
    1