BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6303649 · Received February 6, 2017

    Report

    Report Number
    1226348-2017-10087
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 17, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SENSOR WAS RETURNED FOR EVALUATION. A REVIEW OF QUALITY RECORDS WAS PERFORMED AND THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE INTERNAL CATHETER WAS BROKEN INSIDE THE CATHETER. THE CATHETER MATERIAL WAS STRETCHED/ALTERED 40.2 CM FROM THE TIP. THE CATHETER WAS MASHED 31.1 CM AND 32.5 CM FROM THE TIP. BASED ON THE CONDITION OF THE DEVICE AS RETURNED, NO FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION OF THE DEVICE, THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED COMPLAINT AND DETERMINED THE CAUSE OF FAILURE TO BE RELATED TO MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING NEURO ICU MONITORING: MICROSENSOR GIVING INACCURATE READING. THERE WAS A REFERENCE NUMBER ON ICP PROBE IE, 480 IN OPERATING THEATRE. THE MACHINE WAS DISCONNECTED FROM THE PROBE AND REFIN ICU SAID 500, THE STAFF COULD NOT RESET BACK TO REF 480 AND READINGS WERE INCORRECT. THEY TRIED SEVERAL OTHER MACHINES UNTIL THEY FELT THE READINGS WERE CORRECT. THEY WANT THE MICROSENSORS CHECKED. ICU DEPT TRIED SEVERAL OTHER MACHINES UNTIL THEY FELT THE READINGS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88099 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1