BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6154676 · Received December 8, 2016

    Report

    Report Number
    1226348-2016-10846
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 8, 2016
    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 510(K) # FOR SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION -- DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR?, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, ADDITIONAL MFR NARRATIVE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS WAS CONDUCTED AND THE DEVICE WAS FOUND TO HAVE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND AN UNKNOWN FILM ON THE SENSOR ARE THAT WAS NOT A PART OF THE MANUFACTURING PROCESS. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. THE DEVICE FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    FAILURE DURING PLACEMENT. NO CONSEQUENCES TO THE PATIENT - ANOTHER LIKE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806657 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CVGBC7

    Patients

    Seq Age Sex Outcome Treatment
    1