BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6141052 · Received December 2, 2016

    Report

    Report Number
    1226348-2016-10833
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 10, 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

    THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS FOUND THAT THE DEVICE MET ALL QUALITY AND MANUFACTURING TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THE CATHETER MATERIAL WAS MASHED 6.3 CM FROM THE CONNECTOR. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE DEVICE FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    STANDARD TREATMENT ACTIONS IN CONNECTION WITH HIGH ICP WAS IMPLEMENTED. CT WAS PERFORMED. NEUROSURGEON AND PERSON IN CHARGE OF PATIENT WERE KEPT INFORMED. AFTER CT, ICP WAS MEASURED VIA EVD AND SHOWED A PRESSURE OG 4MMHG VS CODMAN ICP EXPRESS 18MMHG. THE NEUROSURGEON DECIDED TO DISCONTINUE THE MICROSENSOR. THE SENSOR WAS CHECKED VS AIR AND SHOWED A VALUE OF 8MMHG BEFORE IT SUDDENLY DROPPED TO -44 MGHG. AFTER THE SENSOR WAS PUT IN WATER IT SHOWED 7-8 MMHG. THE REFERENCE NUMBER WAS CHECKED AND IT WAS CORRECT (508). IN (B)(6) 2016 WE HAD LOTS OF INCIDENTS WITH THE EQUIPMENT AND ALL THE MONITORS AND CABLES WERE CHANGED. THIS INCIDENT LOOKS LIKE THE ONES WE HAD BEFORE WE SWITCHED THE EQUIPMENT. WE WOULD CODMAN TO CHECK THE USED EQUIPMENT AND MICROSENSOR. PER REP: LIKE I STATED IN THE COMPLAINT FORM THE INCIDENT HAPPENED POST OPERATIVELY. NOTHING HAPPENED TO THE PATIENT. THE SENSOR WAS REMOVED. ALL THE PRODUCTS INVOLVED WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793314 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| (B)(4)