BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD 700 COMPRESSION SYSTEM-US

    MDR report key: 3192539 · Received June 19, 2013

    Report

    Report Number
    1717344-2013-00435
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/18/2013. 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 A SCD CONTROLLER. THE CUSTOMER STATES THE CONTROLLER SPARKS WHEN PLUGGED INTO THE WALL OUTLET. THE CUSTOMER STATES THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278880 SCD 700 COMPRESSION SYSTEM-US SCD CONTROLLER JOW COVIDIEN 29525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK