BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5865127 · Received August 10, 2016

    Report

    Report Number
    1226348-2016-10569
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 27, 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

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALAUTION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL OR CONNECTOR. THE DEVICE FAILED A 2-HOUR DRIFT TEST; HOWEVER, THIS IS NOT RELATED TO THE REPORTED ISSUE. THE DEVICE PASSED ALL REMAINING DRIFT TESTS, AND ALL ELECTRONIC, NOISE, AND LINEARITY/HYSTERESIS TESTS. 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

    COULDN'T GET A P TO ZERO WITH MULTIPLE ATTEMPTS TRYING DIFFERS ICP BOXES AND TRANSDUCER CABLES. EVENTUALLY OPENED A SECOND MICROSENSOR AND HAD THE SAME PROBLEM WITH 2 TO 3 TRIED WITH DIFFERENT ICP UNITS AND TRANSDUCER CABLES. EVENTUALLY DISCONNECTED THE PATIENT MONITOR TO ICP BOX CABLE AND IT WORKED. ON BENCH TESTING FOUND THAT ALL ICP BOXES AND TRANSDUCER CABLES ARE WORKING CORRECTLY WHICH WOULD SUGGEST PROBLEM WAS WITH MICROSENSOR. ADDITIONAL TIME ADDED TO TREATMENT: 45 MINS ADVERSE AFFECTS TO PATIENT: NO PRODUCT TO RETURN: YES WILL GET NEXT WEEK'S HEN DECONTAMINATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518532 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CTJCGY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention