BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 1980288 · Received February 2, 2011

    Report

    Report Number
    1226348-2011-00038
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE SUPPLIER PERFORMED THIS EVAL AND DURING THE INVESTIGATION, IT WAS EXPLAINED THAT THE SUPPLIER WAS UNABLE TO CONDUCT A REVIEW OF THE QUALITY RECORDS BECAUSE THE DEVICE SERIAL NUMBER WAS MISSING. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: THE CATHETER HAS BEEN TORN IN TWO. THE SERIAL NUMBER BAR CODE IS MISSING FROM THE CONNECTOR. NO TESTING WAS POSSIBLE. BASED ON THE ABOVE EVAL, IT APPEARS THAT INADEQUATE USE BY THE CUSTOMER HAS CAUSED THE ACTUAL DAMAGES AND THE DIFFICULTY REPORTED. NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFTER MRI, THE ICP SENSOR COULDN'T MEASURE. IT WAS NOT REPORTED IF THE MONITORING WAS CONTINUED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT NEUROMONITOR BASIC KIT GWM CODMAN & SHURTLEFF, INC., MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK