BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GB SCD EXPRESS COMP SYSTEM X1

    MDR report key: 3222157 · Received July 2, 2013

    Report

    Report Number
    3006451981-2013-00212
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/01/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN SCD PUMP. THE CUSTOMER STATES THE PUMP WAS USED IN OPERATING ROOM, A BANG WAS HEARD AND BLUE SPARKS WERE SEEN. THE PUMP WAS UNPLUGGED. IT WAS DISCOVERED THAT THE MAIN CABLE IS SCORCHED NEAR THE PUMP INLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300624 GB SCD EXPRESS COMP SYSTEM X1 SCD PUMP JOW COVIDIEN 95251S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK