BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 2904513 · Received December 5, 2012

    Report

    Report Number
    1717344-2012-01214
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    November 28, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CUSTOMER STATES THE UNIT WILL NOT CHARGE, WHEN THEY PLUGGED INTO THE WALL OUTLET SPARKS WERE SEEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK