BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,

    MDR report key: 3221854 · Received July 9, 2013

    Report

    Report Number
    8010219-2013-00007
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE UNIT COULD NOT BE BOOTED AND IT DID NOT WORK. THE PRODUCT PROBLEM WAS DISCOVERED ON THE PT'S SECOND DAY WAS IN THE INTENSIVE CARE UNIT (ICU) AFTER THE PT HAD A DECOMPRESSIVE CRANIECTOMY OR SEVERE TRAUMATIC BRAIN INJURY WITH ICP MONITORING. THE CATHETER USED AS A 1104G (SUBDURAL POST CRANIOTOMY ICP MONITORING KIT). THE ICU NURSE FOUND THE CAM-01 WAS SUDDENLY IN A BLACK SCREEN. THERE WAS NO PT HARM OR INJURY. A REPLACEMENT PRODUCT WAS AVAILABLE TO BE USED; RECONNECTED TO ANOTHER CAM-01. THERE WAS NO SURGERY PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313743 CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT, NA GWM INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1