BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5441188 · Received February 17, 2016

    Report

    Report Number
    1226348-2016-10119
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 20, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FOR SIMILAR PRODUCT CODE OF 826631: K914479. (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    I HAD SOME TROUBLE WITH THE NEW ICP PROBES LAST NIGHT WHEN I WAS TRYING TO ICP MONITOR A LADY IN (B)(6) WHO HAD A VERY TIGHT LOOKING SCAN AND A GCS OF 8. SO THE FIRST ONE HAD AN OPENING PRESSURE OF 4MMHG AND INITIALLY THE WAVEFORM WAS GOOD BUT WHEN WE STARTED CLOSING THE WOUND THE TRACE HAD ALTERNATION FLAT LINE AND GOOD WAVEFORM. I DECIDED TO CHANGE BOTH THE BOX AND THE PROBE. THE NEXT PROBE HAD AN OPENING PRESSURE OF 2 WHICH WAS SOMEWHAT SURPRISING GIVEN THE SCAN FINDINGS. AS THE WAVEFORM WAS GOOD WITH THAT PROBE I LEFT IT IN FOR ABOUT AN HOUR AND HALF. WHAT CONCERNED ME WAS THAT THE ICP WAS READING NEVER ROSE ABOVE 6 EVEN WHEN SHE WAS LAID FLAT AND BEING TURNED. I FOUND ONE OF THE OLD WHITE PROBES AND PUT THAT IN INSTEAD WITH AN OPENING PRESSURE ON 12MMHG! (B)(6) HAD PATIENT THIS WEEK WHOSE ICP WAS READING NEGATIVE DESPITE A SCAN SHOWING A HORRIBLE CONTUSION AND MIDLINE SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97794 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CTJB5M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention