BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP EXPRESS IEC

    MDR report key: 4132935 · Received October 1, 2014

    Report

    Report Number
    1226348-2014-12016
    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 THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. 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". (B)(6) 2014, ADDITIONAL INFORMATION STATED: THE PS HAS CONFIRMED THAT THE PROCEDURE DID NOT GO AHEAD, THEREFORE THERE IS NO DELAY TO REPORT. 1 - WERE THE THREE UNITS ATTEMPTED TO BE USED ON THE SAME PATIENT? YES. 2 - 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. 3 - 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
    613287 ICP EXPRESS IEC DEVICE- INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF LE12442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention