BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 13361948 · Received January 26, 2022

    Report

    Report Number
    2031642-2022-00265
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 18, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE SERVICE ENGINEER REVIEWED THE LOGS, THE CUSTOMER WAS INFORMED THAT THE MESSAGE ENCOUNTERED AT THE TIME OF THE EVENT, WAS NOT SYNONYMOUS WITH A MALFUNCTION, BUT WAS A LIMIT OF NORMAL OPERATION OF THE DEVICE WHICH WAS BEING USED IN HIGH FLOW THERAPY MODE. THE CUSTOMER WAS ADVISED TO CHECK THE SIZE OF THE NASAL CANNULA; CHECK THE POSITIONING OF THE CANNULA (IF ONE OF THE 2 ORIFICES OF THE NASAL CANNULA IS BLOCKED, THIS WILL CREATE RESISTANCE TO THE FLOW AND THE DEVICE WILL NOT BE ABLE TO DELIVER THE TARGET FLOW RATE SET BY THE USERS); AND CHECK THAT THE TARGET FLOW (SET FLOW) IS NOT TOO HIGH. MULTIPLE GOOD FAITH EFFORTS (GFE) WERE PERFORMED TO OBTAIN FURTHER DETAILS REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS PROVIDED. IT COULD NOT BE VERIFIED IF THE RECOMMENDED CHECKS ASSISTED IN RESOLVING THE REPORTED ISSUE, AND IF THE DEVICE WAS RETURNED TO SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6). REPORTING INSTITUTION PHONE: (B)(6). REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS A FLOW MALFUNCTION WITH THE VENTILATOR. IT WAS UNKNOWN HOW THE ISSUE WAS FOUND; NO PATIENT OR USER HARM WAS REPORTED. THE SERVICE ENGINEER (SE) WAS ABLE TO SEE IN THE LOGS THAT THE SERVICE HAD USED THE DEVICE IN OHD MODE (HIGH FLOW OXYGENATION). THE SE ENCLOSED THE SECURITY NOTIFICATION THAT WAS SENT TO INFORM THE CUSTOMER ABOUT THE PARTICULARITY OF THE OHD MODE. IT WAS ALSO ENCLOSED A REMINDER ABOUT OHD MOUNTING TO CHECK THE SIZE OF THE NASAL CANNULA CHECK THE POSITIONING OF THE CANNULA (IF ONE OF THE 2 ORIFICES OF THE NASAL CANNULA IS BLOCKED, THIS WILL CREATE RESISTANCE TO THE FLOW, AND THE DEVICE WILL NOT BE ABLE TO DELIVER THE TARGET FLOW RATE SET BY THE USERS) AND CHECK THAT THE TARGET FLOW (SET FLOW) IS NOT TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590954 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown