BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX PHONATORY AERODYNAMIC SYSTEM

    MDR report key: 16861510 · Received May 2, 2023

    Report

    Report Number
    MW5117219
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Report Date
    April 28, 2023
    Manufacturer
    PENTAX OF AMERICA, INC.
    Product Code
    KLX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GOOD MORNING, AFTER REVIEWING THE IFU ON REPROCESSING THE PENTAX PAS SYSTEM, I DISCOVERED THAT THE IFU IS ASKING TO REPROCESS THE DEVICE WITH DAKIN'S SOLUTION. DAKIN'S IFU SPECIFIES THAT THE ANSWER IS FOR WOUND CARE, NOT HARD SURFACES. I HAVE HAD MEETINGS WITH PENTAX TO REPORT THIS OVERSITE OR TO HELP SUGGEST OTHER SOLUTIONS WE HAVE TO REPROCESS, AND THEY ARE NOT RECEPTIVE. I APPRECIATE YOUR HELP, (B)(6) PLEASE LET ME KNOW IF YOU WOULD LIKE ME TO EMAIL THE IFU. AIRFLOW HEAD-TO-MASK COUPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882862 PENTAX PHONATORY AERODYNAMIC SYSTEM ELECTROGLOTTOGRAPH KLX PENTAX OF AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown