BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARENCHYMAL PRESSIO CATHETER

    MDR report key: 6325864 · Received February 13, 2017

    Report

    Report Number
    3001587388-2016-16396
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    August 19, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SOPHYSA SA
    Product Code
    GWM
    PMA / PMN Number
    K062584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO SOPHYSA IN-HOUSE PROCESS, THE PROBE (B)(4) HAS BEEN ANALYZED BY OUR QUALITY CONTROL LABORATORY. NO VISUAL DEFECT WAS OBSERVED. SOME DEPOSITS ARE PRESENT ON THE PA TUBING. ONCE CONNECTED TO A PRESSIO MONITOR, THE ERROR 001 WAS CONFIRMED. THEN, THE CATHETER HAS BEEN OPENED AND IT WAS OBSERVED THAT THE GREEN AND ORANGE MICRO WIRES INSIDE WERE BROKEN. THIS BREAKAGE IS PROBABLY DUE TO AN EXCESSIVE TRACTION ON THE TUBING OF THE PROBE. THE ICP PRESSIO CATHETERS ARE FLEXIBLE, BUT CANNOT BE BENT IN A SUCH WAY WITHOUT INDUCING AN IMPAIRMENT.

    Description of Event or Problem · 1

    PROBLEM WITH ICP CATHETER: AFTER 2 HOURS, THE MONITOR STARTED TO SHOW A VERY LOW NEGATIVE READING AND THEN ERROR CODE "005".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108992 PARENCHYMAL PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA SA ICP CATHETER D0086

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization