BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6753601 · Received July 31, 2017

    Report

    Report Number
    1226348-2017-10525
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    July 7, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS WAS PERFORMED AND FOUND THAT THE COMPONENT MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED SENSOR FOUND THAT THE EPOXY BALL WAS PARTIALLY DISLODGED AT THE END OF THE SENSOR CASE. THIS IS NOT PART OF THE MANUFACTURING PROCESS. THE CATHETER MATERIAL WAS MELTED 8.5 CM FROM THE TIP OF THE SENSOR CASE AND KINKED 4.3 CM FROM THE TIP OF THE SENSOR CASE. THE DEVICE PASSED ELECTRONIC, NOISE, AND LINEARITY/HYSTERESIS TESTS. THE SENSOR FAILED THE DRIFT TEST AT DAY SEVEN OF THE TEST. IT IS SUSPECTED THAT THE EPOXY BALL SEPARATION CONTRIBUTED TO THESE RESULTS. THE DRIFT FAILURE, WHICH WAS OBSERVED ON A DAMAGED, USED SENSOR, WAS 1.6 MMHG OUT OF SPEC ON THE SEVENTH DAY OF TESTING AND WOULD HAVE MINIMAL EFFECT ON CUSTOMER'S USE. BASED ON THE SUPPLIER'S EVALUATION OF THE DEVICE, THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PROBE SHOWS AGAIN WRONG NUMBERS LIKE ALL THE OTHER COMPLAINT PROBES FROM THIS HOSPITAL SEND YOU BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534637 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1