BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS W/EXT HOOK

    MDR report key: 3963887 · Received May 21, 2014

    Report

    Report Number
    3006451981-2014-00636
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    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) 2014. 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) 2014 THAT AN SCD CONTROLLER WAS RETURNED TO A LOCAL COVIDIEN SERVICE CENTER AS A BACK TO STOCK UNIT. A SERVICE TECHNICIAN FOUND THAT THE POWER CORD WAS CUT EXPOSING THE AC NEUTRAL COOPER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301184 SCD EXPRESS W/EXT HOOK SCD CONTROLLER JOW COVIDIEN U9525E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK