BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-PTO

    MDR report key: 18901589 · Received March 14, 2024

    Report

    Report Number
    3006942548-2024-00004
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    December 11, 2023
    Report Date
    March 14, 2023
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: ON 02/27/2024, IT BECAME KNOWN THAT THE CATHETER COMPLAINED ABOUT WAS NO LONGER AVAILABLE FOR INVESTIGATION PURPOSES. A REVIEW OF THE PRODUCTION DOCUMENTS SHOWS THAT THE CATHETER WAS MANUFACTURED AND DELIVERED IN ACCORDANCE WITH THE SPECIFICATIONS. ALTHOUGH A MALFUNCTION DURING APPLICATION CANNOT BE RULED OUT WITH ABSOLUTE CERTAINTY, IT MUST BE TAKEN INTO ACCOUNT THAT THE PTIO2 VALUE IS A SECONDARY, NON-VITAL PARAMETER THAT ONLY PROVIDES SUPPLEMENTARY INFORMATION. AGAINST THIS BACKGROUND, A FAILURE OF THE PTIO2 MEASUREMENT FUNCTION COULD NOT IN PRINCIPLE HAVE LED TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH, EVEN IF THE ERROR PATTERN WOULD OCCUR AGAIN (NO MALFUNCTION RECUR).

    Description of Event or Problem · 0

    FROM OUR DISTRIBUTOR WE RECEIVED ON 02/15/2024 THE FOLLOWING INFORMATION REGARDING A CATHETER NEUROVENT-PTO (095008-001) : THE OXYGEN VALUE DURING A CONTINOUS MONITORING DIDN'T WORK. A CT WAS PERFORMED TO CHECK THE CATHETER COLLACATION, WHICH WAS RIGHT. INSTRACTION WERE GIVEN THE NEUROSURGEON TO OPEN THE SCREW AND TURN THE PROBE ACCORDINGLY THE CATHETER WAS REMOVED AS THE VERY SAME DAY THE EVENT DID NOT AFFECT THE HEALTH STATUS OF THE PATIENT, NO ADDITIONAL SURGERY OR MEDICAL TREATMENT WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077575 NEUROVENT-PTO NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095008-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown