BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6803713 · Received August 18, 2017

    Report

    Report Number
    1226348-2017-10635
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    August 3, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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); 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 MICROSENSOR WAS EVALUATED BY THE SUPPLIER. REVIEW OF MANUFACTURING RECORDS FOR THE RETURNED COMPONENT FOUND THAT THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THE CATHETER MATERIAL APPEARED TO BE MELTED 0.8 CM FROM THE TIP. 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. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A ROHS MICROSENSOR GAVE AN INACCURATE READING. AN ICP LINE WAS TUNNELED AND HAD A ZERO REFRERENCE OF 477. DURING WOUND CLOSURE, IT WAS NOTED THAT THE BOX SPONTANEOUSLY STOPPED WORKING, SHOWING A BLANK SCREEN. THE CABLE TO THE BACK OF THE BOX WAS LOOSE. WHEN TIGHTENED, THE BOX WAS SWITCHED BACK ON BUT WAS SHOWING A CLEARLY INACCURATE NUMBER. THE MONITOR WAS SWITCHED OFF AND ON AND THE CABLE WAS REPLACED, WITH NO EFFECT. A NEW MONITOR WAS USED WITH NO IMPROVEMENT. THE ICP LINE WAS THEN CHANGED AND THE SENSOR EXPLANTED AND RE-ZEORED. THE PROCEDURE WAS PROLONGED BY 45 MINUTES TO AN HOUR. PATIENT HAD A NEW LINE TUNNELLED AND SENSOR RE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584246 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ICP EXPRESS CABLE| UNKNOWN ICP EXPRESS MONITOR