BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 10344241 · Received July 30, 2020

    Report

    Report Number
    3003768277-2020-00044
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 14, 2020
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K141979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INSPECTED THE SYSTEM ON SITE AND IT WAS CONFIRMED THAT THE SYSTEM WAS WORKING ACCORDING TO SPECIFICATIONS. NO MALFUNCTION OF THE SYSTEM WAS IDENTIFIED VIA INSPECTION AND TESTING OF THE SYSTEM. PHILIPS ANALYZED THE LOG FILES OF THE SYSTEM AND CALCULATED THAT THE PATIENT RECEIVED A RADIATION DOSE OF 8.2 GY. AS ALSO SPECIFIED IN THE INSTRUCTIONS FOR USE (4522 203 29802, CHAPTER 2.1) DETERMINISTIC EFFECTS OR TISSUE REACTIONS MAY OCCUR WHEN THE RADIATION DOSE HAS EXCEEDED A CERTAIN THRESHOLD LEVEL. THE THRESHOLD DOSE IS TYPICALLY 2 GY FOR TRANSIENT SKIN ERYTHEMA (REDNESS OF THE SKIN) AND 3 GY FOR TEMPORARY HAIR LOSS. ANALYSIS OF THE LOG FILES DID NOT IDENTIFY ANY ERRORS OR ISSUES WITH THE SYSTEM. BASED ON THE INVESTIGATION RESULTS, PHILIPS HAS CONCLUDED THAT THERE WAS NO MALFUNCTION OF THE SYSTEM. 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

    THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS AFTER A NEURO PROCEDURE THE PATIENT EXPERIENCED HAIR LOSS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809171 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722028 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other