BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM

    MDR report key: 3810695 · Received March 21, 2014

    Report

    Report Number
    8010219-2014-00012
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT (CAM01) "PRESSURE MONITOR NOT WORKING." THE EVENT WAS FOUND DURING SETUP AND WAS DESCRIBED AS FOLLOWS: "THE PROBLEM IS THE CONNECTOR ON THE SIDE OF THE CAMINO FOR THE PAC CABLE WAS LOOSE AND SOMETIMES THE SIGNAL IS LOST AND NO DATA SHOWS." THEY NOTICED THIS DURING TRAINING OF THE STAFF AND NOT DURING USAGE; THEREFORE, THERE WAS NO PATIENT CONTACT OR DELAYS FOR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169654 CAMINO ADVANCED MONITOR WITH ICP WAVEFORM NA GWM INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1