BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHIO MEDICAL

    MDR report key: 11859712 · Received May 20, 2021

    Report

    Report Number
    1419185-2021-00006
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 20, 2021
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021 OHIO MEDICAL RECEIVED A COMPLAINT REGARDING O2 HUMIDIFIER. THE END USER ATTEMPTED TO USE THE HUMIDIFIER WITH A PNEUMATIC NEBULIZER. THE CUSTOMER STATED IT WOULD NOT WORK; THE END USER BLOCKED THE SAFETY VALVE IN AN ATTEMPT TO USE THE HUMIDIFIER WITH A NEBULIZER. THE HUMIDIFIER BOTTLE BROKE DUE TO MISUSE; HOWEVER, NO USER OR PATIENT HARM OCCURRED. THE CUSTOMER CONFIRMED FOR OHIO MEDICAL THAT THEY REITERATED TO THE END USER THAT BLOCKING THE SAFETY VALVE IS NOT WITHIN THE INTENDED USE. ON (B)(6) 2021 THE DISTRIBUTOR FOLLOWED UP WITH OHIO MEDICAL. THE END USER INQUIRED ABOUT HUMIDIFIER PRODUCT OPTIONS WHICH COULD BE USED WITH A NEBULIZER. THE DISTRIBUTOR REITERATED TO THE END USER THAT BLOCKING THE SAFETY VALVE IS NOT WITHIN THE INTENDED USE. OHIO MEDICAL COMMUNICATED THE CUSTOMER FEEDBACK TO THE ORIGINAL DEVICE MANUFACTURER. PER THE INSTRUCTIONS OF THE HUMIDIFIER MANUAL "PURPOSE: THE OXYGEN HUMIDIFIER USES THE BUBBLE TYPE HUMIDIFICATION PROCESS TO PROVIDE STABLE MOISTURE CONTENT FOR MAXIMUM PATIENT COMFORT DURING THE ADMINISTRATION OF OXYGEN." THE ENGINEERING TEAM CONFIRMED A NEBULIZER IS MEANT TO DELIVER MEDICATION TO A PATIENT AND IS NOT MEANT TO BE USED WITH A HUMIDIFIER. A HUMIDIFIER IS TO BE USED AT LOW DELIVERY OF OXYGEN TO CREATE MOISTURE. ON (B)(6) 2021 THE DEVICE MANUFACTURER NOTIFIED OHIO MEDICAL AN ADDITIONAL WARNING WILL BE ADDED TO INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751943 OHIO MEDICAL HUMIDIFIER KFZ 6700-0338-800 NI

    Patients

    Seq Age Sex Outcome Treatment
    1