BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO S5/S5I SERIES INTRAVASCULAR IMAGING

    MDR report key: 2052056 · Received March 2, 2011

    Report

    Report Number
    2939520-2011-00006
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K082229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PC MODULE WAS RETURNED TO VOLCANO FOR EVALUATION. THE SIDE PANEL WAS REMOVED AND THE ALL COMPONENTS WERE INSPECTED UNDER A LIGHT MICROSCOPE. DISCOLORATION WAS OBSERVED UNDER THE CHIP FOLLOWING THE CAT5 CABLE CONNECTION. THE PINS ON THE CHIP WERE REMOVED TO FURTHER EXAMINE THE CHIP; IT WAS OBSERVED THAT THE WIRE COATINGS WERE BURNT. THIS CHIP IS A PASSIVE COMPONENT, WHICH SUGGESTS AN OVER-CURRENT WAS APPLIED; HOWEVER, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS FAILURE. A REPLACEMENT PC MODULE WAS INSTALLED AND THE SYSTEM IS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    DURING SYSTEM SERVICE BY A FIELD SERVICE ENGINEER (FSE) DUE TO A REPORTED IMAGE ISSUE, A PC MODULE WAS REPLACED. POST REPLACING THE PC MODULE, IT WAS NOTICED THAT THE EXTERNAL USB EXTENDER (REX) WAS DAMAGED, SPECIFICALLY, THE PORT CONNECTION ON THE REX WAS BROKEN. THIS WAS DUE TO THE BEDSIDE CONTROL CONSOLE CABLES BEING WRAPPED AROUND THE TABLE SIDE; THUS THE REX WAS REPLACED. POST REPLACING THE REX, THE SYSTEM WAS FUNCTIONAL FOR A FEW PROCEDURES AND THEN EXPERIENCED BEDSIDE CONTROL LOCK UP; AND IT WAS NOTICED THAT THE REX LIGHTS DID NOT ILLUMINATE. IN TURN THE REX WAS AGAIN TESTED BY THE FSE ON ANOTHER FUNCTIONAL SYSTEM AND IT DID ILLUMINATE; THEN HE REMOVED THE SIDE PANEL FROM THE PC MODULE AND DISCONNECTED THE INTERNAL CAT5 CABLE TO INSPECT THE CAT5 BULKHEAD CONNECTOR. AT THIS TIME THE FSE INDICATED HE COULD SMELL SOMETHING SIMILAR TO A HOT COMPONENT AND SMOKE WAS NOTED. THE DEVICE WAS REMOVED FROM SERVICE. THERE WAS NO PT HARM OR SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLCANO S5/S5I SERIES INTRAVASCULAR IMAGING ULTRASONIC IMAGING SYSTEM IYO VOLCANO CORPORATION 807401001-R

    Patients

    Seq Age Sex Outcome Treatment
    1