BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 6499561 · Received April 18, 2017

    Report

    Report Number
    3003768277-2017-00040
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    April 7, 2017
    Report Date
    April 10, 2017
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA .

    Additional Manufacturer Narrative · 1

    PHILIPS INVESTIGATED THIS COMPLAINT AND CAME TO THE FOLLOWING CONCLUSION: THE DOSE VALUES WITH PRE FILTER (0.1 CU + 1.0 MM AL) WERE 10 TIMES TOO HIGH. DURING THE LAST TUBE YIELD CALIBRATION THE PHILIPS FIELD SERVICE ENGINEER HAS INCORRECTLY ENTERED THE MEASURED VALUES. AS A RESULT THE DOSE VALUES WITH PRE FILTER (0.1 CU + 1.0 MM AL) WERE 10 TIMES TOO HIGH. SO THE PATIENT DID NOT RECEIVE A HIGH DOSE, BUT 10 TIMES LESS AS INDICATED IN THE INITIAL REPORT. THEREFORE WE DO NOT CONSIDER THIS AS A SERIOUS INJURY. THE FIELD SERVICE ENGINEER COULD CORRECT THIS ISSUE AND THE TUBE YIELD AND EDL CALIBRATION ARE NOW CORRECT ON THIS SYSTEM. A FORMAL COMMUNICATION HAS BEEN SENT OUT TO INFORM THE PHILIPS FIELD SERVICE ENGINEERS IN FRANCE IN ORDER TO INFORM THEM ABOUT THIS PROBLEM.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER IN WHICH IT WAS STATED THAT A PATIENT RECEIVED 6.795 GY DURING A PROCEDURE. THE CUSTOMER USED 19 MINUTES OF FLUORO AND 34 SEQUENCES 963 IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281270 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS HEALTHCARE 722003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other