BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS CNTRLR W/OUT BATT

    MDR report key: 2949635 · Received November 27, 2012

    Report

    Report Number
    1717344-2012-01186
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE ON: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS NON-SPECIFIC ISSUE. THE UNIT WAS RETURNED TO A COVIDIEN SERVICE CENTER. UPON TRIAGE, SERVICE TECH FOUND POWER CORD IS CUT AND INNER COPPER WIRES ARE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS CNTRLR W/OUT BATT SCD PUMP GEI COVIDIEN 9526 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN