BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19469321 · Received June 5, 2024

    Report

    Report Number
    3003768277-2024-03190
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 23, 2024
    Report Date
    July 29, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED DEVICE WAS NOT IN CLINICAL USE DURING THE ISSUE OCCURRENCE. A PHILIPS FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM ONSITE AND CONFIRMED THAT THERE WAS A DELAYED RELEASE OF X-RAYS FOR BOTH FLUOROSCOPY AND CINE. REVIEW OF THE LOG FILES SHOWED AN ERROR CODE XSC TUBE CURRENT OUT OF RANGE. UPON FUNCTIONAL TESTING, FSE FOUND THAT THE IMAGE WAS WHITE WHEN X-RAYS WERE DONE OR DELAYED. AFTER FURTHER TESTING, IT WAS DISCOVERED THAT THE GRID SWITCH LEAKAGE WAS 5600 NGY, WHICH IS TOO HIGH. TO RESOLVE THE ISSUE, THE FSE REPLACED THE X-RAY TUBE AND CALIBRATED ALL THE SPECIFICATIONS. THE EQUIPMENT PERFORMED NORMALLY. ALL THE FUNCTIONALITY OF THE EQUIPMENT HAS BEEN CHECKED AND PASSED. AFTER THE REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THERE WAS A DELAYED RELEASE OF X-RAYS FOR BOTH FLUOROSCOPY AND CINE THAT RESULTED IN WHITE IMAGES. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPLACED THE X-RAY TUBE AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523246 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown