BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD10

    MDR report key: 12074924 · Received June 28, 2021

    Report

    Report Number
    3003768277-2021-10029
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    June 18, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: PHILIPS HAS INVESTIGATED THIS ISSUE. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE AND ANALYZED THE LOGFILE AND NO FAILURE OF THE SYSTEM WAS IDENTIFIED. THE SYSTEM WAS WORKING ACCORDING TO SPECIFICATION. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO GET FURTHER INFORMATION REGARDING PATIENT AND SEQUENCE OF EVENTS OF THE REPORTED PROBLEM. HOWEVER, THE CUSTOMER HAS INDICATED THAT THEY WILL NOT PROVIDE ANY ADDITIONAL INFORMATION. AS NO ADDITIONAL INFORMATION IS PROVIDED FOR INVESTIGATION, PHILIPS IS CLOSING THIS COMPLAINT AND THIS EVENT WILL BE INCLUDED IN THE POST MARKET SURVEILLANCE TREND ANALYSIS. CORRECTED DATA: UPDATED CODES BASED ON INVESTIGATION AND ADDED PATIENT WEIGHT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT WHILE TRANSFERRING THE PATIENT FROM THE ALLURA SYSTEM TO THE GURNEY, THE PATIENT FELL ON THE FLOOR. ACCORDING TO THE INFORMATION RECEIVED THE PATIENT SUSTAINED BROKEN RIBS AND A FRACTURED SKULL. PHILIPS HAS STARTED THE INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970899 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 Required Intervention