BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/F SYSTEMS: ANGIO / INTERVENTIONAL

    MDR report key: 8857015 · Received July 31, 2019

    Report

    Report Number
    MW5088693
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    PHILIPS HEALTHCARE NORTH AMERICA / PHILIPS
    Product Code
    OWB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CATH LAB PROCEDURE. THE CATH LAB SYSTEM TABLE ENTERED A "FREE FLOAT" STATE WITHOUT USER INPUT. THE CARM ALSO BEGAN TO MOVE ERRATICALLY ALSO WITHOUT USER INPUT. THE CARM MADE CONTACT WITH THE PT AND DRAGGED ACROSS HIS STOMACH. PROVIDER HAD TO SHIELD PT'S HEAD OUT OF CAUTION WHILE ANOTHER STAFF MEMBER ACTIVATED THE EMERGENCY STOP BUTTON. THE EMERGENCY STOP BUTTON DID FUNCTION, AS DESIGNED. NO PT HARM REPORTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638845 R/F SYSTEMS: ANGIO / INTERVENTIONAL INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE NORTH AMERICA / PHILIPS AZURION 3 F12

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R