BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19231679 · Received May 2, 2024

    Report

    Report Number
    3003768277-2024-02558
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 24, 2024
    Report Date
    January 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059115
    PMA / PMN Number
    K141979
    Removal / Correction Number
    3003768277-12/28/2023-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED TO PROVIDE THE LINKAGE TO AN EXISTING CORRECTION & REMOVAL (3003768277-12/28/2023-010-C). THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE FIELD CORRECTION 3003768277-12/28/2023-010-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF EVENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED EVENT. DURING TROUBLESHOOTING, FSE FOUND THAT THE POWER DISTRIBUTION UNIT(PDU) WAS NOT FUNCTIONING, THE FRONT PANEL OF THE PDU LEDS WAS IN THE STANDBY ERROR STATE AND THE BACK PANEL OF THE PDU LEDS INDICATED THEY WERE IN FAILURE STATE. FSE CONFIRMED THAT THE ROOT CAUSE OF THE ISSUE WAS FAILURE OF THE AC UNIT IN THE EQUIPMENT ROOM CAUSING THE TEMPERATURE TO RISE EXCESSIVELY, LEADING TO THE FAILURE OF SYSTEM ROOM COMPONENTS ON ACCOUNT OF WHICH POWER DISTRIBUTION MODULE(PDM), BACK PANEL OF THE PDU AND IMAGE PROCESSING PC(IPPC) GOT FAULTY. THE AC EQUIPMENT WAS REPLACED BY THE HOSPITAL STAFF. FSE REPLACED PDU, FRONT PANEL AND BACK PANEL OF PDU AND IPPC TO RESOLVE THE ISSUE. THE DEFECTIVE PDU, FRONT PANEL OF PDU, BACK PANEL OF PDU AND IPPC WERE RETURNED FOR ANALYSIS. PART ANALYSIS OF THE PDU INDICATED THAT THE PDM WAS NOT TURNING ON WHEN CONNECTED TO GPDU. PART ANALYSIS OF REAR PANEL OF THE PDU INDICATED THAT A CABLE WAS DEFECTIVE AND FUSE FAILED. PART ANALYSIS OF FRONT PANEL OF THE PDU DOES NOT INDICATE ANY MALFUNCTION WITH THE PART. PART ANALYSIS OF IPPC INDICATED THAT THE POWER SUPPLY OF THE IPPC FAILED. AFTER REPLACEMENT OF IPPC, PDU AND REAR PANEL OF PDU, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOTUP. NO PATIENT OR USER HARM WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450054 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/15 00884838059115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown