BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT.

    MDR report key: 3624295 · Received December 9, 2013

    Report

    Report Number
    8010219-2013-00019
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 26, 2013
    Report Date
    December 9, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF THREE FROM THE SAME FACILITY. THE REPORT INVOLVES A CAM01. THIS CAM01 WAS USED DURING A TRAINING SESSION THAT WAS SCHEDULED AS A RESULT THE EVENT THAT OCCURRED WITH MFR REPORT NUMBERS 8010219-2013 ((B)(4)) AND 2023988-2013-00023 ((B)(4)). THE EVENT WAS DESCRIBED AS FOLLOWS; THE CLINICAL EDUCATOR USED THE CAM01 MONITOR TO PROVIDE AN IN-SERVICE TRAINING FOR THE THEATRE STAFF AND INTENSIVE CARE UNIT NURSES AND DURING THIS TRAINING SHE NOTED THAT THE MONITOR WAS NOT "DUMPING" INTRACRANIAL PRESSURE TREND INFO WHEN THE 1104 B CATHETER WAS DISCONNECTED AND RE-CONNECTED INTERMITTENTLY OR AFTER A PERIOD OF --2 HOURS OF DISCONNECTION. THERE WAS NO INJURY OR DELAY INVOLVED WITH THIS EVENT AS THIS OCCURRED DURING A TRAINING SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639713 CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT. NA GWM INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1