BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 2440322 · Received February 1, 2012

    Report

    Report Number
    3003768277-2012-00005
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    January 15, 2012
    Report Date
    January 16, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULT, CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    WHEN THE OPERATOR PLACED THE HEADSET ON THE HEAD OF THE PT, IT FRACTURED AND A PIECE OF THE HEADSET INJURED THE PT'S EYE. THE PT WAS TREATED BY A DOCTOR SUCCESSFULLY TO PREVENT PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH PHILIPS HEALTHCARE 781196

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention