BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR

    MDR report key: 4110562 · Received September 16, 2014

    Report

    Report Number
    3006697299-2014-00096
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (RELAND) LIMITED
    Product Code
    GWM
    PMA / PMN Number
    K121573
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON AN UNK DAT, THE DEMONSTRATION CAMINO MONITOR WAS TESTED AND IT RETAINED THE TREND INFO FOLLOWING DISCONNECTION OF A FIBEROPTIC PROBE. ADD'L INFO WAS RECEIVED ON (B)(6) 2014: THERE WAS NO PT IMPACT. THE PRODUCT PROBLEM WAS DETECTED AS DEFECTIVE BY THE INTEGRA SALES REP DURING DEMONSTRATION IN THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572691 INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR ICP MONITORING GWM INTEGRA LIFESCIENCES (RELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1