BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 13939420 · Received March 29, 2022

    Report

    Report Number
    3001587388-2022-22090
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 28, 2022
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    UDI-DI
    03760124131758
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR ANALYSIS ON 03/07/2022. ASPECT CONTROL : THE DEVICE RETURNED IN DRY CONDITIONS IN ITS ORIGINAL PACK. ESTIMATED INSERTION DEPTH 45MM (TIGHTENING MARKS). THE DEVICE PRESENTS FEW MARKINGS AND A YELLOW COLOR TO AN ORANGE COLOR ON THE PA TUBE. FUNCTIONAL CONTROL : WHEN FIRST CONNECTED (IN RETURN STATE), THE DISPLAYED VALUES OF TEMPERATURE AND PRESSURE ARE STABLE. WHEN SIMULATED IN TESTING, THE SENSOR REACTS NORMALLY. WHEN TESTED IN A WATER COLUMN UNDER DIFFERENT PRESSURE VALUES, THE SENSOR IS STABLE, FOR 24HOURS. CONCLUSION : IN ITS RETURNED STATE, THE DEVICE IS WITHIN SPECIFICATIONS AND THE REPORTED PROBLEM CANNOT BE REPRODUCED NOR CONFIRMED.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED A DIFFERENCE BETWEEN ICP VALUES AND DISPLAYED AMPLITUDE ON THE MONITOR; NO HEALTH CONSEQUENCES REPORTED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759747 SOPHYSA PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT GWM SOPHYSA PSO-PBT 03760124131758

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other