BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5781995 · Received July 11, 2016

    Report

    Report Number
    1226348-2016-10493
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 20, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF MANUFACTURING RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTIN/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE CATHETER FOUND THAT THE SENSOR WAS NOT FUNCTIONAL. THE CATHETER MATERIAL AND INTERNAL WIRES WERE BROKEN, AND THE INTERNAL WIRES WERE EXPOSED. THE CATHETER WAS RECEIVED IN A TIGHTLY COILED CONFIGURATION HELD TOGETHER WITH STRING. BASED ON THE CONDITION OF THE DEVICE WAS IT WAS RECEIVED, NO FURTHER FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED COMPLAINT AND DETERMINED THE CAUSE OF FAILURE TO BE MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4); 510 (K) # FOR SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE ICP PROBE 62-6631 HAD BEEN INSERTED LAST WEEK BUT ON MONDAY (B)(6) 2016 IT STARTED GIVING NEGATIVE READINGS WITH A FLAT TRACE. A CT SCAN CONFIRMED IT WAS IN POSITION IN THE BRAIN. THE PROBE WAS REMOVED FOR CLINICAL REASONS AS THE PATIENT WAS IMPROVING. THERE IS NO CLEAR REASON WHY THE PROBE STARTED GIVING INACCURATE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435677 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1