BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5634097 · Received May 5, 2016

    Report

    Report Number
    1226348-2016-10341
    Event Type
    Injury
    Date Received
    May 5, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) #'S: K061876 & K050739. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE MADE AVAILABLE FOR EVALUATION. IT WAS LATER COMMUNICATED THAT THE DEVICE WOULD NOT BE RETURNED. THIS REPORT HAS BEEN UPDATED TO REFLECT THIS CORRECTED INFORMATION. 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.

    Description of Event or Problem · 1

    PRODUCT FAILED TO GIVE CONFIRMATION DESPITE MOVING VALVE TO CORRECT SETTING. COMMENTS FROM ACCOUNT: WE JUST HAD TO CHANGE A MEDOS VALVE ON A NICU PT. DID NOT GET MACHINE TO CONFIRM SETTING, BUT DID SWITCH ON X-RAY. DIFFICULT TO CHANGE DUE TO PT'S SMALL SIZE AND TRACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288294 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention