BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS CONTROLLER

    MDR report key: 3003556 · Received February 11, 2013

    Report

    Report Number
    1717344-2013-00080
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 28, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    THE CUSTOMER RETURNED THE UNIT BACK TO STOCK TO COVIDIEN SVC CTR. UPON TRIAGE, SVC TECH FOUND THE POWER CORD IS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59974 SCD EXPRESS CONTROLLER SCD PUMP JOW COVIDIEN U9525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK