BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 12590044 · Received October 7, 2021

    Report

    Report Number
    3003768277-2021-10164
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 8, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085367
    PMA / PMN Number
    K172822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTL NARRATIVE: PHILIPS INVESTIGATED THIS COMPLAINT. WHILE PERFORMING 3DRA CALIBRATIONS OF THE SYSTEM, THE ENGINEER MOVED THE TABLE, GRABBED THE TABLE RAIL AND HIS FINGER GOT ENTRAPPED IN THE LONGITUDINAL GUIDING PROFILES. THERE WAS NO MALFUNCTION OF THE SYSTEM.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT WHEN SERVICING THE AZURION SYSTEM A PHILIPS ENGINEER GOT INJURED. THE ENGINEER WAS MOVING THE TABLE INTO POSITION WHEN THE TIP OF HIS LITTLE FINGER GOT SMASHED BY THE TABLE BEARING. THE FINGER TIP WAS STITCHED BACK TOGETHER, THE BONE WAS CRUSHED AND WILL NOT REATTACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485935 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838085367

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention