BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG BORE

    MDR report key: 1156269 · Received September 4, 2008

    Report

    Report Number
    1525965-2008-00018
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    PHILLIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MALFUNCTION WAS DISCOVERED DURING USE BUT DID NOT AFFECT PATIENT OUTCOME. FURTHER INVESTIGATION OF THIS ISSUE IS BEING CONDUCTED. AN UPDATED FORM 3500A WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. MDR SUBMIITED ON 04SEPT08. ADDITIONAL CATALOG# NCTA541.

    Description of Event or Problem · 1

    THE TRANSDUCER USED FOR PULMONARY GATING OF A CT SYSTEM SEEMS TO BE RELAYING INACCURATE SIGNALS IN THE BELLOWS SYSTEM. THIS COULD RESULT IN AN IMAGE BEING DISPLAYED WITH AN INCORRECT PHASE OF THE RESPIRATORY CYCLE WHICH MAY THEN BE USED TO JUDGE TREATMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG BORE X-RAY CT SCANNER SYSTEM/JAK JAK PHILLIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1