BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP EXPRESS IEC

    MDR report key: 4132930 · Received October 1, 2014

    Report

    Report Number
    1226348-2014-12017
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 17, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK945585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ALL THREE REPORTED ICP EXPRESS UNITS P/N 82-6635; S/N'S (B)(4), (B)(4), (B)(4) WERE NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. IN THE ABSENCE OF THE COMPLAINT SAMPLES THE MANUFACTURING RECORDS FOR THESE THREE UNITS WERE REVIEWED AND IT WAS VERIFIED THAT ALL THREE UNITS WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED FROM MANUFACTURING ON JUNE 27, 2012. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. HOWEVER, IF ANY OF THESE THREE UNITS BECOME AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE AFFILIATE INFORMED THAT: "3 ICP EXPRESS UNITS HAD SYSTEM FAILURE. REP WAS CONTACTED BY PHONE TO HELP TROUBLESHOOT BUT ERROR PERSISTED. AS A RESULT, PROCEDURE WAS POSTPONED (POTENTIALLY FOR (B)(6) 2014 IF LOAN UNIT IS RECEIVED). PATIENT'S CONDITION IS UNKNOWN, BUT THERE WERE NO REPORTED ADVERSE EVENTS APART FROM THE PROCEDURE BEING CANCELLED". ON 9/22/2014 ADDITIONAL INFORMATION STATED: THE PS HAS CONFIRMED THAT THE PROCEDURE DID NOT GO AHEAD, THEREFORE, THERE IS NO DELAY TO REPORT. WERE THE THREE UNITS ATTEMPTED TO BE USED ON THE SAME PATIENT? YES. PROCEDURE WAS POSTPONED (POTENTIALLY FOR (B)(6) 2014, IF LOANER UNIT IS RECEIVED). COULD YOU PLEASE LET US KNOW THE PATIENT'S CONDITION? THE PATIENT HAS NOT UNDERGONE THE PROCEDURE THE PRODUCT SPECIALIST HAS NOT BEEN ADVISED WHEN THE PATIENT WILL UNDERGO THE PROCEDURE. NO CHANGE TO THE PATIENT'S CONDITION HAS BEEN REPORTED I.E. NO ADVERSE EVENT. COULD YOU PLEASE LET US KNOW THE SERIAL NUMBERS OF THE THREE ICP EXPRESS UNITS INVOLVED WITH THIS ISSUE? (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612346 ICP EXPRESS IEC DEVICE- INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention