BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM

    MDR report key: 2192905 · Received July 25, 2011

    Report

    Report Number
    2939520-2011-00050
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K082229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSION): THE SYSTEM UNIT WAS REPLACED AND OPERATIONAL. (B)(4). THE REPORTED SYSTEM UNIT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING INVESTIGATION, THE CPU WAS REMOVED FROM THE SYSTEM AND INTERNAL COMPONENTS WERE VISUALLY INSPECTED. A BURNED SMELL WAS PRESENT. VISUAL INSPECTION REVEALED A BURNED AREA ON THE BACK PLANE NEAR THE POWER HARNESS, CONSISTENT WITH A +12V TO GROUND SHORT. FURTHER INSPECTION FINDS THE +12V FAN POWER CABLE IS SHORTED TO GROUND AT THE TIE POINT ON THE VGA SPLITTER STANDOFF. THE +12V POWER CABLE WAS PINCHED BETWEEN THE VH+ DATA CABLE FERRITE AND THE METAL VGA SPLITTER MOUNTING BRACKET, SHORTING THE +12V WIRE TO CHASSIS GROUND. THE PINCH WAS DUE TO INSUFFICIENT CLEARANCE BETWEEN THE FERRITE AND THE MOUNTING BRACKET WHEN THE SYSTEM'S REAR COVER IS CLOSED. THE MANUFACTURER WILL UPDATE THE CURRENT PROCESS ON ROUTING OF THE FAN WIRING TO ELIMINATE POTENTIAL FUTURE WIRE PINCHING. THE COMPLAINT DATABASE WAS REVIEWED AND THERE WAS NO OTHER COMPLAINTS REPORTED FOR THIS FAILURE MODE FOR THIS SYSTEM. THE MANUFACTURING DOCUMENTATION FOR THIS WAS REVIEWED AND THE SYSTEM MET ALL QUALITY AND MANUFACTURING RELEASED CRITERIA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE MANUFACTURER'S DISTRIBUTOR REPORTED THAT A BURNT SMELL WAS OBSERVED WHEN THE SYSTEM WAS POWERED ON. THE POWER CABLE WAS IMMEDIATELY DISCONNECTED AND MOVED THE SYSTEM TO ANOTHER ROOM. WHILE IN THE NEW ROOM, THE SYSTEM WAS POWERED UP ONCE AGAIN AND SMOKE CAME OUT FROM THE SYSTEM. THE MANUFACTURER REPRESENTATIVE VISITED THE COMPANY ON (B)(6) 2011 AND CONFIRMED THAT THE BACK PLANE BOARD WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASOUND IYO VOLCANO CORPORATION 804200001

    Patients

    Seq Age Sex Outcome Treatment
    1