BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR ADAPT CABLE, ICP, HP, MERLIN SERIES

    MDR report key: 2833907 · Received November 7, 2012

    Report

    Report Number
    8010219-2012-00032
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED ON (B)(4) 2012, VERIFIES PT INVOLVEMENT. THE DESCRIPTION IS AS FOLLOWS; "SHORTLY AFTER THE FACILITY RECEIVED THE ICP-39 ADAPTOR CABLE FOR A PHILIPS VIEWLINK MODULE. (THE SIGNAL WAS INVERTED AT THE PHILIPS PT MONITOR (WITH A NEGATIVE NUMERICAL VALUE), THIS PT WAS THE VERY FIRST PT ICU USED THIS CABLE WITH... TWO CABLES WITH THIS ORDER AND THE SHIPPING BOXES WERE INTACT AND NONE OF THE TWO CABLES HAD ANY NOTICEABLE DAMAGE. THE INTENSIVE CARE STAFF COULDN'T UNDERSTAND HOW THE WAVEFORMS WERE "WEIRD" LOOKING AND THE NUMERICAL VALUES WERE NEGATIVE ON THE (BEDSIDE) PT MONITOR COMPARED TO THE VALUE ON THE ICP MONITOR ITSELF. THE BIOMED WAS CALLED AND AFTER TROUBLESHOOTING THE INVESTIGATION DETERMINED THAT PIN OUTPUTS WERE MIXED UP. SINCE THE CABLE WERE JUST REMOVED FROM THE SHIPPING CONTAINER AND USED WITH A PT SHORTLY AFTER, I FEEL THAT I COMFORTABLY CAN CALL IT "OUT OF THE BOX FAILURE" SINCE THEY FAILED WITH THE VERY FIRST CASE. AFTER PINNING OUT THE CABLE AND FOUND THE MIXED PIN-OUT MEASUREMENTS WHICH WAS VERIFIED AND WITNESSED BY MY COLLEAGUES, AN X-RAY IMAGE OF IT WAS DONE TO SEE IF THERE WAS A DIFFERENCE BETWEEN THIS AND A NORMALLY FUNCTIONING CABLE. THE RESULTS LOGICALLY EXPLAINED THE OBSERVED MALFUNCTION (NEGATIVE VALUES AND REVERSED WAVEFORM TO THE BEDSIDE MONITOR)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONITOR ADAPT CABLE, ICP, HP, MERLIN SERIES NA LFL INTEGRA NEUROSCIENCES, LTD. 04712

    Patients

    Seq Age Sex Outcome Treatment
    1