BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20 OR TABLE

    MDR report key: 5185063 · Received October 28, 2015

    Report

    Report Number
    3003768277-2015-00092
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 29, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OBW
    PMA / PMN Number
    K133239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CONTACT OFFICE ADDRESS (B)(4).

    Additional Manufacturer Narrative · 1

    A PHILIPS SERVICE ENGINEER WENT ON SITE BUT WAS UNABLE TO OBTAIN LOG FILES TO TROUBLESHOOT THE ISSUE. DUE TO THE NATURE OF THE ERROR NO DOSE REPORT WAS AVAILABLE, BUT THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT THE PHILIPS SERVICE ENGINEER WAS UNABLE TO REPLICATE THE REPORTED ISSUE ON THE SYSTEM AND COULD NOT FIND ANYTHING OUT OF THE ORDINARY. SINCE WE COULD NOT REPLICATE THE ISSUE AND NO LOG FILES ARE AVAILABLE, WE SEE THIS ISSUE AS A ONE TIME OCCURRENCE. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER IN WHICH THEY STATED THAT A PATIENT WAS HARMED DUE TO RECEIVING A HIGHER DOSE THAN NECESSARY. PHILIPS IS IN THE PROCESS OF ACQUIRING MORE DETAILED INFORMATION FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716139 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