BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR

    MDR report key: 4110542 · Received September 16, 2014

    Report

    Report Number
    3006697299-2014-00099
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    GWM
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAM02 CAMINO ADVANCED MONITOR WAS NOT SOUNDING THE ALARM PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573798 INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR ICP MONITORING GWM INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1