BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD 700 COMPRESSION SYSTEM-US

    MDR report key: 3842572 · Received February 24, 2014

    Report

    Report Number
    3006451981-2014-00537
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/24/2014. 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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN SCD PUMP. THE CUSTOMER STATES AT THE TIME OF INSPECTION, THE POWER CABLE WAS RUPTURED AND THE INNER COOPER WIRES WERE EXPOSED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111757 SCD 700 COMPRESSION SYSTEM-US SCD PUMP JOW COVIDIEN 29525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK