BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT

    MDR report key: 12460014 · Received September 13, 2021

    Report

    Report Number
    3001587388-2021-21413
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    May 28, 2021
    Report Date
    September 8, 2021
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE POS-PN (SN° (B)(4)) WAS IMPLANTED IN REPLACEMENT TO A PREVIOUS PSO-PB (SN° (B)(4)). THE LATTER WAS RELATED TO CASE N°2021412. IT WAS IMPLANTED TO PATIENT WITH NO PROBLEM AND ZEROING PROCESS WAS EVENTLESS. THE DEVICE STARTED TO WORK CORRECTLY BUT AFTER A FEW MINUTES THE VALUES DISPLAYED ON THE MONITOR BECAME INCOHERENT. THE PSO-PB WAS THE EXPLANTED TO BE REPLACED BY ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355930 PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT GWM SOPHYSA PSO-PB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R