BEUDAMED
    FDA Adverse Event Other Summary report: N

    GB SCD EXPRESS COMP SYSTEM X1

    MDR report key: 2042182 · Received March 30, 2011

    Report

    Report Number
    1310379-2011-00029
    Event Type
    Other
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 10, 2011
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SCD EXPRESS PUMP. THE CUSTOMER STATES THAT A MEMBER OF STAFF HAD AN ELECTRIC SHOCK WHEN REMOVING PLUG FROM SOCKET. THE CUSTOMER REPORTS THAT THE NURSE HAD A SMALL ELECTRICAL SHOCK AND THERE WAS NO HARM TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GB SCD EXPRESS COMP SYSTEM X1 SCD EXPRESS PUMP JOW COVIDIEN 95251S V0521312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other