BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 13962465 · Received March 31, 2022

    Report

    Report Number
    3001587388-2022-22022
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    December 29, 2021
    Report Date
    March 30, 2022
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ELONGATION TRACES WERE FOUND ON THE MONITORING DEVICE (PA TUBE), WHICH WAS 30MM SUPERIOR TO A NORMAL LENGTH. THIS ELONGATION WOULD LIKELY CAUSE A BREAKAGE TO THE ELECTRIC MICRO WIRE. THIS EFFECT IS MOST LIKELY DUE TO A TRACTION THAT THE DEVICE UNDERWENT DURING IMPLANTATION (BY USER).

    Description of Event or Problem · 0

    ICP MONITORING DEVICE IMPLANTED TO A PEDIATRIC PATIENT ON (B)(6) 2021. SURGEON REPORTED NO ANOMALY DURING INITIAL SURGERY. ZEROING PROCEDURE TO CALIBRATE THE DEVICE WAS SUCCESSFUL. FOUR HOURS AFTER SURGERY, THE MONITOR DISPLAYED ERROR "E001". THE SURGEON STATED THAT DEVICE WAS NEITHER DAMAGED NOR PULLED. HOWEVER, DEVICE WAS EXPLANTED AND REPLACED TO CONTINUE MONITORING. NO MEDICAL CONSEQUENCES ON THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042990 SOPHYSA KIT PRESSIO® POUR MONITORING DE PIC, PARENCHYMATEUX TUNNELLISABLE GWM SOPHYSA PSO-PT

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Other