BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 7195146 · Received January 16, 2018

    Report

    Report Number
    1226348-2018-10071
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    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 · 0

    THE SENSOR WAS RETURNED FOR EVALUATION. A REVIEW OF QUALITY RECORDS FOR THE COMPONENT FOUND THAT THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. EVALUATION OF THE RETURNED DEVICE FOUND A FILM RESIDUE OVER THE SENSOR AREA THAT IS NOT PART OF THE MANUFACTURING PROCESS. THE SENSOR BALANCE WAS LOW UPON RECEIPT. ONCE THE FILM RESIDUE WAS REMOVED, SENSOR BALANCE WAS NORMAL. THERE WERE SLIGHT BENDS ALONG THE CATHETER BODY, WITH SUTURE ATTACHED TO THE CATHETER MATERIAL. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY AND SIGNAL DRIFT TESTS. IT WAS CONFIRMED THAT THERE WAS AN ISSUE WITH THE SENSOR. ONCE THE FILM RESIDUE WAS REMOVED, THE DEVICE FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, AGAIN A PROBE WITH WRONG SCORES OVER 40MM. PLEASE CHECK PROBE. NO REPORTED PATIENT HARM. ISSUE OCCURRED INTEROPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40398 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1