BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD 700 COMPRESSION SYSTEM - US

    MDR report key: 2843579 · Received October 24, 2012

    Report

    Report Number
    3006451981-2012-00180
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 17, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SCD PUMP. THE UNIT WAS RETURNED TO A COVIDIEN SERVICE CENTER. UPON TRIAGE, SERVICE TECH FOUND THE UNIT'S POWER CORD IS CUT OPEN SHOWING COPPER WIRING. THERE IS ALSO ARCING BETWEEN THE WIRES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK