BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS REFURBISHED

    MDR report key: 2843580 · Received October 24, 2012

    Report

    Report Number
    1717344-2012-01124
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 12, 2012
    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) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED TO A COVIDIEN SERVICE CENTER. UPON TRIAGE, SERVICE TECH FOUND THE POWER CORD WAS DAMAGED, WIRE WAS SHOWING, AND ARCING IS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS REFURBISHED SCD PUMP JOW COVIDIEN 9525R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK