BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 6043618 · Received October 20, 2016

    Report

    Report Number
    3003768277-2016-00100
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 10, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS INVESTIGATED THIS COMPLAINT AND CAME TO THE FOLLOWING CONCLUSION: A PHILIPS FIELD SERVICE ENGINEER WENT ON SITE AND CONFIRMED THAT THE ROADMAP FUNCTION DID NOT WORK. WHEN INVESTIGATING THE ISSUE HE FOUND THAT IN THE BACK PANEL THE SLOT OF THE IMAGE PROCESSING BOARD THE PINS WERE BENT. THESE PINS WERE PROBABLY BENT WHEN THIS BACK PANEL WAS REPLACED DURING AN EARLIER CORRECTIVE MAINTENANCE. THESE PINS CAN BEND WHEN THE BOARD IS NOT PLACED PRECISELY IN THE DESIGNATED SLOT. THE PHILIPS PRODUCT DESIGNER AND COMPLAINT INVESTIGATOR HAVE ANALYZED THE EVENT LOG FILE AND FOUND OUT THAT THE PATIENT RECEIVED A TOTAL AIR KERMA OF 0,73 GY. SINCE THE TOTAL AMOUNT OF DOSE RECEIVED BY THE PATIENT DOES NOT EXCEED 2 GY, NO RADIATION RELATED INJURIES ARE EXPECTED FOR THE INVOLVED PATIENT. BASED ON TRENDING ANALYSIS THERE IS NO EXCEPTIONAL REPLACEMENT RATE FOR THE REPLACED ITEMS, THEREFORE WE TAKE NO FURTHER ACTION REGARDING THESE PARTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER IN WHICH WAS STATED THAT DURING A THROMBECTOMY IT SHOWED THAT THE ROADMAP FUNCTION DID NOT WORK. THEREFORE A PATIENT WAS X-RAYED WITH 121 MICROGRAY PER SQUARE CENTIMETER FOR 5 MINUTES. ACCORDING TO THE CUSTOMER THE ROAD MAP PROBLEMS OCCURRED DURING TREATMENT ON THE (B)(6). DUE TO THAT AN ANGIOGRAPHY COULD NOT BE PERFORMED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696058 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other