BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX 8000

    MDR report key: 2713528 · Received August 22, 2012

    Report

    Report Number
    1525965-2012-00057
    Event Type
    Death
    Date Received
    August 22, 2012
    Date of Event
    February 2, 2007
    Report Date
    June 6, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K982060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THIS COMPLAINT REPORTED A DEATH WHILE A PATIENT WAS ON A PHILIPS HEALTHCARE CT SCANNER. AS NOTED, THE PATIENT EXPIRED WHEN A BIOPSY NEEDLE WAS INSERTED INTO THE CHEST. THE BIOPSY WAS BEING PERFORMED ON THE CT SCANNER USING THE CCT MODE. THE VERSION OF SOFTWARE ON THIS CT SCANNER AT THE TIME OF THE EVENT ((B)(6) 2007) DID NOT LET THE OPERATOR SELECT THE CCT IMAGE DISPLAY ORIENTATION. THE SOFTWARE VERSION OF THE MX8000 QUAD CT SCANNER WAS 2.64 AND DID NOT PERMIT THE REQUESTED FUNCTION. THERE WAS NO SYSTEM FAILURE AS THE CT SCANNER OPERATED AS DESIGNED. THE NEGATIVE PATIENT OUTCOME WAS NOT DUE TO THE CT SCANNER AS IT FUNCTIONED AS INTENDED. THE ISSUE WAS DEEMED TO BE A USE ERROR. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPIRED WHEN A BIOPSY NEEDLE WAS INSERTED INTO THE CHEST. THE BIOPSY WAS DONE USING THE CCT MODE ON THE CT SCANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX 8000 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728201

    Patients

    Seq Age Sex Outcome Treatment
    1