BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO S5/S5I SERIES INTRAVASCULAR IMAGING

    MDR report key: 2060786 · Received March 11, 2011

    Report

    Report Number
    2939520-2011-00008
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K082229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN REC'D BY THE MANUFACTURER SO A DEVICE EVALUATION HAS NOT BEEN PERFORMED YET. THE REPORTED COMPLAINT OF BURNT SPOT AND DAMAGED POWER SUPPLY HARNESS IS CONFIRMED BASED ON PICTORIALS PROVIDED FROM THE REPORTER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVALUATION SYSTEM FAILED WHEN IT WAS POWERED UP AT A CUSTOMER SITE AND SMOKE WAS NOTED. THE SYSTEM'S BACK PANEL WAS REMOVED FOR VISUAL INSPECTION AND A BURNT SPOT WAS NOTICED ON THE SYSTEM'S PASSIVE BACKPLANE BOARD. ALSO, THE POWER SUPPLY HARNESS EXHIBITED DAMAGE. THE SYSTEM WAS REMOVED FROM SERVICE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLCANO S5/S5I SERIES INTRAVASCULAR IMAGING ULTRASONIC IMAGING SYSTEM IYO VOLCANO CORPORATION 804200001-R

    Patients

    Seq Age Sex Outcome Treatment
    1