BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6775335 · Received August 8, 2017

    Report

    Report Number
    1226348-2017-10555
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 13, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE OR, THE NEUROSURGEON WANTED TO IMPLANT A CODMAN MICROSENSOR REFER 62-6631 (LOT UNKNOWN). THEREFORE, THE DIRECTLINK MODULE REFER 82-6828 WAS COUPLED TO THE BEDSIDE MONITOR (DRÄGER) AND THE CALIBRATION PROCEDURE WAS PERFORMED TO CALIBRATE THE DIRECTLINK MODULE WITH THE BEDSIDE MONITOR. ONCE THIS WAS DONE, THE 62-6631 WAS COUPLED TO THE DIRECTLINK MODULE AND THE ZEROING PROCEDURE FOR THE 62-6631 WAS PERFORMED. AFTER ZEROING, THE VALUE DISPLAYED ON THE BEDSIDE MONITOR WAS MINUS TWO AND NOT ZERO AS IT SHOULD BE BECAUSE AT THAT MOMENT THE SENSOR IS NOT YET IMPLANTED. THE OR NURSES AND NEUROSURGEON DID NOT MANAGE TO BRING THE VALUE TO ZERO. THE PATIENT WAS TRANSFERRED FROM THE OR TO THE INTENSIVE CARE UNIT AND THE MESSAGE FROM THE OR TO THE HEAD NURSE OF THE INTENSIVE CARE WAS TO TAKE THIS ISSUE INTO ACCOUNT. NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554530 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1