BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5657667 · Received May 16, 2016

    Report

    Report Number
    1226348-2016-10374
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    April 25, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PN/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 MICROSENSOR WAS RETURNED FOR EVALUATION BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS WAS CONDUCTED AND IT WAS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED SENSOR FOUND THAT THE PRESSURE SENSOR AND CASE WERE MISSING, AND THE CATHETER MATERIAL HAD BEEN STRETCHED AND BROKEN. BASED ON THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. HOWEVER, THEY DETERMINED THE CAUSE OF THE CONDITION THE DEVICE WAS IN TO BE MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. REFER TO MDR 1226348-2016-10373 FOR INFORMATION RELATED TO THE ADDITIONAL DEVICE INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ICP MEASUREMENT RANDOM AND NOT ACCURATE ACCORDING TO STATE OF PATIENT. PATIENT PRESENT A VENTRICULAR HEMORRHAGE. PATIENT TREATED WITH ICP MEASUREMENT WITH EVD CATHETER AND EXTERNAL DRAINAGE. ICP MEASUREMENT SHOWS READING FROM 1 TO 20 WITH PEAK TO 60 UNBELIEVABLE ACCORDING TO PATIENT STATE. THE PATIENT IS EXTUBATED AND CONSCIOUS, LEAD SURGEON TO NOT TRUST ICP MEASUREMENT. AFTER IRM THE VALUES OF ICP MEASUREMENT DROPPED TO - 1 --9 SURGEONS THINKS IT'S MORE ACCURATE TO REALITY OF STATE OF PATIENT. THANKS FOR INVESTIGATING THE ICP PROBE AND WAIT FOR THE REPORT. ON 4/29/2016 PER REP: "THE DEVICE IS CURRENTLY IN USE NOT REMOVED. THE MICROSENSOR WILL BE SENT FOR EVALUATION AS SOON AS POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312964 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention