BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3790872 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11557
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 24, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. THE REPORTING DECISION HAS BEEN CHANGED TO MALFUNCTION. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING EVALUATION A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: CATHETER MATERIAL STRETCHED AND BROKEN. INTERNAL CATHETER WIRES EXPOSED AND BROKEN. EXPOSED CATHETER WIRES TIED IN A KNOT AND TAPED TO CONNECTOR. SUTURE AND TAPE ATTACHED TO CATHETER MATERIAL. BLACK MARKING (499) ON CONNECTOR. NO TESTING POSSIBLE. BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER DURING USE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT 38 HOURS AFTER SURGERY, THE MICRO SENSORS STARTED TO READ ERRATIC READINGS. SENSOR WAS REMOVED AND FOUND TO BE QUITE DAMAGED. REQUEST FOR AN EXPLANATION ON WHY THIS PROBLEM HAS OCCURED AND QUERY AS TO THE DURABILITY OF SENSOR. (AFTER USE ON PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266826 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1