BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD10

    MDR report key: 14785443 · Received June 23, 2022

    Report

    Report Number
    3003768277-2022-00294
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    June 10, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE REPORTED PROBLEM. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE AND IDENTIFIED A DEPOSIT OF CONTRAST PRODUCT ON THE TABLE PIVOT WHICH RESULTED IN LESS RESISTANCE WHEN IN A SPECIFIC PIVOT STOP POSITION. THE DEPOSIT WAS REMOVED, AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. CORRECTED DATA: CODING UPDATED BASED ON INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT WHILE TRANSFERRING THE PATIENT FROM THE TABLE TO THE STRETCHER, THE TABLE UNEXPECTEDLY PIVOTED. THE PATIENT IS APPROXIMATELY 100KG AND HAS NO LEGS. THREE STAFF MEMBERS PREVENTED HIM FROM FALLING AND WERE INJURED. THIS REPORT CONCERNS A PATIENT TRANSPORTER WHO INJURED THEIR WRIST WHILE HELPING TO CATCH THE PATIENT AND KEEP HIM FROM FALLING. NO HARM HAS BEEN REPORTED ON THE PATIENT. AS THIS INCIDENT RESULTED IN THREE STAFF MEMBERS BEING INJURED AND A PATIENT NEARLY FALLING OFF THE TABLE, FOUR COMPLAINTS HAVE BEEN REPORTED. THE OTHER THREE REPORTS CAN BE FOUND UNDER PHILIPS REFERENCE NUMBERS (B)(4). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239683 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other