BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 12084201 · Received June 29, 2021

    Report

    Report Number
    3003768277-2021-10030
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 8, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDL NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE PATIENT WAS PREPARED FOR AN ANGIOPLASTY PROCEDURE WITH THE SHEATH INSERTED WHEN IT WAS IDENTIFIED THAT DIGITAL SUBTRACTION ANGIOGRAPHY WAS NOT POSSIBLE, A MESSAGE WAS SHOWN ¿EXPOSURE NOT POSSIBLE. IMAGE DISK FULL¿. FLUOROSCOPY WAS STILL POSSIBLE. THE USER DELETED IMAGES FROM THE HARD DISK BUT THIS DID NOT RESOLVE THE PROBLEM. THE PROCEDURE WAS ABORTED, THE SHEATH WAS REMOVED, AND THE INCISION WAS CLOSED WITH A CLOSURE DEVICE. WITH THE USE OF A CLOSURE DEVICE A PATIENT CAN BE AMBULATORY AFTER CLOSURE OF THE INCISION. PHILIPS CONCLUDES THAT THE FAILURE OF THE ALLURA SYSTEM DID NOT CONTRIBUTE TO THE PATIENT STAYING OVERNIGHT. A PHILIPS ENGINEER INSPECTED THE SYSTEM ONSITE AND ANALYZED THE LOG FILE AND CONFIRMED THAT THE HARD DISK DRIVES OF THE IMAGE PROCESSING PC FAILED. THE IMAGE PROCESSING PC WAS REPLACED AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO GET INFORMATION REGARDING PATIENT INFORMATION. HOWEVER, THE CUSTOMER HAS NOT PROVIDED ANY PATIENT INFORMATION. CORRECTED DATA: CHANGED FROM ADVERSE EVENT TO PRODUCT PROBLEM AS WITH THE USE OF A CLOSURE DEVICE A PATIENT CAN BE AMBULATORY AFTER CLOSURE OF THE INCISION. PHILIPS CONCLUDES THAT THE FAILURE OF THE ALLURA SYSTEM DID NOT CONTRIBUTE TO THE PATIENT STAYING OVERNIGHT.. UPDATED CODES.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT CINE AND SUBTRACTED RUNS WERE NOT POSSIBLE DURING AN ANGIOPLASTY PROCEDURE. THE PROCEDURE WAS ABORTED AND RESCHEDULED TO THE NEXT DAY. THE PATIENT HAD TO STAY IN THE HOSPITAL OVERNIGHT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982899 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 Hospitalization