BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS CONTROLLER

    MDR report key: 2963062 · Received January 25, 2013

    Report

    Report Number
    1717344-2013-00050
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SCD PUMP. THE CUSTOMER STATES WHEN THE UNIT WAS PLUGGED INTO A POWER STRIP, SPARKS WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35403 SCD EXPRESS CONTROLLER SCD PUMP JOW COVIDIEN U9525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK