BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5936222 · Received September 8, 2016

    Report

    Report Number
    1226348-2016-10638
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    June 19, 2016
    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

    THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED, AS THE BAR CODE LABEL WITH THE DEVICE IDENTIFIER WAS MISSING FROM THE SENSOR. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE SENSOR PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE REPORTE 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

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

    Description of Event or Problem · 1

    "THE CLINICIAN STATED THAT HE WAS EXPERIENCING A PROBLEM WITH A CODMAN MICROSENSOR. THE CLINICIAN IMPLANTED A CODMAN MICROSENSOR INTO A PATIENT WHO WAS HAVING A SUBDURAL CRANIOTOMY. HE NOTICED A NEGATIVE READING WHICH HAS NOT IMPROVED POST OPERATIVELY. IT APPEARS THAT THE MICROSENSOR HAS BEEN ZERO' CORRECTLY WHEN ASKED. THE CLINICIAN MENTIONED THAT THE MICROSENSOR WAS YELLOW. THE MICROSENSOR SHOULD BE WHITE. I HAVE ASKED THE CLINICIAN TO KEEP THIS ONCE EX-PLANTED SO WE CAN SEND TO COMPLAINTS. PATIENT HAD A NEGATIVE READING OF 2 THEN 6 MMHG. THE CLINICIAN FELT THAT THERE MAY BE A PROBLEM WITH THE MICROSENSOR. MICROSENSOR IS STILL CURRENTLY IMPLANTED AT THIS STAGE." UNKNOWN PATIENT OUTCOME, PATIENT STILL IN ICU. NO PATIENT DEMOGRAPHICS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588702 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention