BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 8110364 · Received November 28, 2018

    Report

    Report Number
    3003768277-2018-00088
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Report Date
    November 13, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. PHILIPS TROUBLE SHOT THE SYSTEM. THE REPORTED PROBLEM OF DISPLAYED DAP VALUE HIGHER THAN THE DOSE DELIVERED WAS REPRODUCED FOR FLUOROSCOPY. A TUBE ADAPTATION, EDL CALIBRATION AND TUBE YIELD CALIBRATION WERE PERFORMED AFTER WHICH THE ISSUE WAS NOT SHOWN ANYMORE. THESE ACTIVITIES HOWEVER DO NOT HAVE AN EFFECT ON THE CALCULATION OF THE DISPLAYED DAP-VALUE. IN CASE OF A DEVIATION IN THE DISPLAYED DAP, THE DEVIATION WOULD ALSO SHOW WITH EXPOSURE. NO LOG FILES OR TRACE FILES WERE AVAILABLE FOR INVESTIGATION. BASED ON AVAILABLE INFORMATION PHILIPS CANNOT DETERMINE WHAT COULD HAVE CAUSED THE REPORTED PROBLEM. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED TO PHILIPS. A DAP MEASUREMENT DEVICE HAS BEEN INSTALLED IN THE SYSTEM. NO REOCCURRENCE HAS BEEN REPORTED SINCE THEN. AT THIS MOMENT, NO FURTHER ACTIONS WILL BE TAKEN BY PHILIPS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS HAS RECEIVED THROUGH THE (B)(6) FEDERAL OFFICE FOR SAFETY IN HEALTH CARE A REPORT SUBMITTED BY A CUSTOMER. IN THIS REPORT, THE CUSTOMER STATED, "DUE TO A CALIBRATION ERROR THE ACTUAL RADIATION DOSE DISPLAYED DEVIATED FROM THE DELIVERED DOSE. THE CLINIC IS CURRENTLY PART OF A PAN-EUROPEAN PROJECT FOR THE DEFINITION OF DIAGNOSTIC REFERENCE VALUES (DRW OR DRL) AND PROVIDES DOSE VALUES (DOSE AREA PRODUCT / DAP AND DOSE AT THE REFERENCE POINT / AIRKERMA) OF DIFFERENT INTERVENTIONS. THE REVIEW OF THE MEASURED DAP WITH THE DAP DISPLAYED BY THE ANGIO SYSTEM SHOWED A DEVIATION OF A FACTOR OF 3. SINCE THE CLINIC HAS AN AUTOMATIC DOSE MONITORING SYSTEM WITH ALERT LEVELS, THESE MESSAGES ARE ALSO FAULTY. THE DATA COLLECTED BY THE CLINIC ARE THUS USELESS. SINCE IT CANNOT BE RULED OUT THAT A CALIBRATION ERROR WILL CAUSE THE INDICATED DOSE TO BE LOWER THAN THE ACTUAL DOSE DELIVERED, THIS EVENT IS REPORTED AS NEAR-MISS. " PHILIPS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949425 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1