BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20 OR TABLE

    MDR report key: 5350966 · Received January 7, 2016

    Report

    Report Number
    3003768277-2016-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 1, 2015
    Report Date
    December 11, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OBW
    PMA / PMN Number
    K133239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL SENT TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    PHILIPS INVESTIGATED THIS ISSUE AND REVIEWED THE LOG FILES WHICH SHOWED THE CUSTOMER PERFORMED A TUBE YIELD CALIBRATION ON THE SYSTEM. THE TUBE YIELD CALIBRATION WAS DONE INCORRECTLY, MOST LIKELY THE MANUALLY SUBMITTED PARAMETERS WERE ENTERED 10 TIMES TOO HIGH. THE CONSEQUENCES OF THE WRONGFULLY EXECUTED CALIBRATION WERE: THE DOSE VALUES THAT THE SYSTEM REPORTS (AIR KERMA AND DAP) WERE 10 TIMES HIGHER THAN THEY ARE IN REALITY. THE SYSTEM RESTRICTS THE DOSE WITH FLUORO, RESULTING IN A IQ REDUCTION DURING FLUORO. THIS MEANS THE REPORTED 9 GY WAS NOT CORRECT, THE PATIENT ONLY RECEIVED 0,9 GY. THE INCORRECT TUBE YIELD CALIBRATION DID NOT RESULT IN EXTRA DOSE FOR THE PATIENTS WE ADVISE THE CUSTOMER TO FOLLOW THE AIAT PROCEDURE WHEN CALIBRATING THE X-RAY TUBE TO PREVENT THE ISSUE FROM OCCURRING AGAIN. THIS AIAT PROCEDURE IS TO BE FOUND ON PHILIPS INCENTER WHICH IS AVAILABLE FOR THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER THAT DURING A CARDIAC CASE THAT HAD 62 MINUTES OF FLUORO AND 31 RUNS, THE PATIENT RECEIVED APPROXIMATELY 9GY OF DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9274 ALLURA XPER FD20 OR TABLE ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER OBW PHILIPS HEALTHCARE 722035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other