BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6136494 · Received November 30, 2016

    Report

    Report Number
    1226348-2016-10820
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 9, 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 DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL OR CONNECTOR. THERE WAS SUTURE ATTACHED TO THE CATHETER. 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

    PROBE SHOWS WRONG NUMBERS, PLEASE CHECK PROBE. PER AFFILIATE: PLEASE PROVIDE MORE DETAILS CONCERNING THE REPORTED INCIDENT. DID THIS EVENT OCCUR INTRA-OPERATIVELY? NO. DID THE REPORTED EVENT CAUSE ANY DELAYS IN THE PROCEDURE OR SURGERY OVER 30 MINUTES? NONE REPORTED. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? UNKNOWN. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT? NON REPORTED. IS THERE A SERIAL OR LOT NUMBER YOU CAN PROVIDE? PERHAPS WHEN THE SALES REP GETS THE SENSOR FROM THE HOSPITAL. WAS THE DEVICE REVISED OR WAS IT REMOVED AND MONITORING DISCONTINUED? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785661 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1