BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUNAV

    MDR report key: 2080212 · Received April 7, 2011

    Report

    Report Number
    3006377159-2011-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K053610
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAS NOT BEEN RETURNED TO PHILIPS AT THIS TIME FOR EVALUATION.

    Description of Event or Problem · 1

    WHILE SUPPORTING A PROCEDURE AT (B)(6) MEDICAL CENTER IN (B)(6), A PHILIPS CLINICAL APPLICATIONS SPECIALIST REPORTED THAT DURING THE TREATMENT ON A PATIENT WITH LIVER LESIONS, THE PERCUNAV SHUT OFF AND THE USER WAS UNABLE TO TURN THE PERCUNAV BACK ON. THE DOCTOR CONTINUED WITH THE PROCEDURE, REVERTING TO THE STANDARD OF CARE CT GUIDANCE, AND THE PERICARDIUM WAS HIT BY THE NEEDLE REQUIRING MEDICAL INTERVENTION. THE NEXT DAY, THE DOCTOR CONFIRMED THAT THE PATIENT IS DOING FINE. THE PHYSICIAN AT THE USER FACILITY CONFIRMED THAT THE PERCUNAV DEVICE WAS NOT INVOLVED ON (B)(6) 2011, DURING A RADIOFREQUENCY ABLATION PROCEDURE COMPLICATED BY PERICARDIAL HEMORRHAGE.

    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 Required Intervention