BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 20281194 · Received September 23, 2024

    Report

    Report Number
    3003768277-2024-05356
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 28, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) EXAMINED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM WAS INTERMITTENTLY SHUTTING OFF WHEN PERFORMING FLUOROSCOPY OR EXPOSURE. THE RSE CHECKED THE SYSTEM REMOTELY AND OBSERVED THAT THE CURRENT ANALYZER WAS LEFT ON DUE TO A POSSIBLE POWER OUTAGE OR DROP OR DUE TO A DROP IN POWER DEDICATED TO THIS EQUIPMENT AND A UPS FAILURE WAS OBSERVED, IT WAS OBSERVED IN THE PREVIOUS CASE THAT THE ANALYZER ALARMED WHEN THE ELECTRICAL PANEL (TE) WAS WITH THE KEYS RAISED, THIS INDICATED THAT THERE WAS NOT NECESSARILY A CUT, BUT A VOLTAGE DROP. THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED ONSITE AND INSPECTED UPS CONNECTED TO GPDU, WHICH HAD INTERNAL FAILURE AND THEREFORE WORKED INTERMITTENTLY. THIS UPS WAS FEEDING AN OLD WORKSTATION (3D) THAT NO LONGER EXISTS, THE POWER WAS FED TO A TRIPLE POWER OUTLET THAT WAS SHORTED AND THEREFORE FAILED AND AFFECTED THE GPDU. THE FSE CONFIRMED THAT THE CAUSE OF THE ISSUE WAS A VOLTAGE DROP IN ONE OF THE PHASES OF THE MAINS. TO RESOLVE THE ISSUE, FSE NORMALIZED THE POWER CABLES AND RECONNECTED ACCORDING TO THE SERVICE MANUAL. ALSO THE IMAGE MODULE ON THE PEDESTAL WAS INSPECTED, WHICH WAS NOT WORKING EVEN THOUGH IT WAS NEW, SINCE IT WAS REPLACED. THE CONNECTION SCHEMATIC WAS REVIEWED, THE CABLES AND CONNECTORS ON THE PEDESTAL, WALL CONNECTION BOX, MDY, 24V DC CHECK, FIRMWARE CHECK WHERE AN ERROR WAS DETECTED IN THE EQUIPMENT CONFIGURATION, WHICH WAS LATER CORRECTED BY FSE TO RESOLVE THE ISSUE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM INTERMITTENTLY SHUT OFF WHEN PERFORMING FLUOROSCOPY OR EXPOSURE. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488929 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown