BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUNAV

    MDR report key: 2152272 · Received June 23, 2011

    Report

    Report Number
    3006377159-2011-00004
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K053610
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS HEALTHCARE HAS BEEN INFORMED BY A SUPPLIER THAT CERTAIN PERCUNAV TOOL CONNECTION UNITS MAY CONTAIN AN ELECTRONIC COMPONENT THAT DOES NOT MEET SPECIFICATION, WHICH COULD CAUSE REGISTRATION DIFFICULTIES AND/OR INACCURATE INSTRUMENT TRACKING. A FIELD CORRECTION WAS REPORTED TO FDA ON (B)(4).

    Description of Event or Problem · 1

    A PHILIPS SALES DEVELOPMENT MGR REPORTED AN INCIDENT INVOLVING THE INABILITY OF THE PERCUNAV IMAGE GUIDED DEMO SYSTEM TO REGISTER TARGET LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUNAV COMPUTED TOMOGRAPHY, X-RAY SYSTEM JAK PHILIPS HEALTHCARE PERCUNAV SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NI