BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 V60PLUS VENTILATOR

    MDR report key: 18741817 · Received February 20, 2024

    Report

    Report Number
    2518422-2024-08659
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 1, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE KEY MARKET (KM) RESPONDER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE KM RESPONDER ALSO CONFIRMED THAT THE DEVICE WAS DISPLAYING A "CHECK VENT: MACHINE PRESSURE SENSOR AUTO ZERO FAILED" ERROR CODE, AND THAT THE ERROR CODE WAS DOCUMENTED IN THE EVENT LOG. THE KM RESPONDER REPORTED THAT THE FLOW SENSOR ASSEMBLY WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE DEVICE WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    E: INNOVATIONS COMPANY LIMITED (B)(6). REPORTER # (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTED THAT THE V60 VENTILATOR DISPLAYED A "CHECK VENT : MACHINE PRESSURE SENSOR AUTO ZERO FAILED" ERROR CODE. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465953 V60 V60PLUS VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown