BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6568934 · Received May 16, 2017

    Report

    Report Number
    1226348-2017-10323
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    April 24, 2017
    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 SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE COMPONENT MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. AFTER THE SENSOR WAS BALANCED, THE DEVICE PASSED ASSL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNLA DRIFT TESTS. THERE WAS A BEND IN THE CATHETER MATERIAL 38.4 CM FROM THE TIP; HOWEVER THIS DID NOT APPEAR TO AFFECT THE FUNCTIONALITY OF THE DEVICE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THE SENSOR 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). PMA/510 (K) # OF PRODUCT CODE 826631: K914479. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION WAS PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. SUBSEQUENTLY, THE DEVICE WAS PROVIDED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR AFTER 5 DAYS SHOWED VERY HIGH INCORRECT VALUES. IT WAS REMOVED AND REPLACED BY A EVD. PER AFFILIATE, NO ADVERSE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350872 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention