BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 16990403 · Received May 24, 2023

    Report

    Report Number
    3003768277-2023-03133
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    February 7, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYZED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM¿S STORAGE WAS ALMOST FULL. UPON TROUBLESHOOTING, RSE FOUND THAT IPPC WAS DEFECTIVE.TO RESOLVE THIS ISSUE, PHILIPS ENGINEER REPLACED HARD DRIVES FOR PC AND RELOADED SOFTWARE TO IPPC. LATER WHICH, THE ISSUE WAS FOUND IN THE IPPC AND IT WAS REPLACED IN THE CASE 0121282476 PR# 3082369. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE GAVE AN ERROR INDICATING THE SYSTEM¿S STORAGE WAS ALMOST FULL, DESPITE THERE NOT BEING ANY PATIENTS ON THE SYSTEM. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650980 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown