BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 3842585 · Received February 24, 2014

    Report

    Report Number
    3006451981-2014-00538
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    January 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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

    THE CUSTOMER REPORTED A NON SPECIFIC ISSUE. THE UNIT WAS SENT TO A COVIDIEN SERVICE CENTER. UPON TRIAGE, A SERVICE FOUND THE POWER CORD IS DAMAGED SHOWING BARE COPPER WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112235 SCD EXPRESS COMPRESSION SYSTEM SCD PUMP JOW COVIDIEN 9525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK