BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4141271 · Received October 3, 2014

    Report

    Report Number
    2031642-2014-01143
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    December 10, 2024
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR HAD AN OXYGEN FLOW PROBLEM. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE FACILITY BIOMEDICAL TECHNICIAN REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY INDICATED OXYGEN PRESSURE CALIBRATION ERROR, DATA ACQUISITION FAILURE, AND OXYGEN DEVICE FAILURE OCCURRENCES. THE FAILURES AS NOTED MAY RESULT IN A VENT INOP CONDITION AND LOSS OF OXYGEN SOURCE. THE VENTILATOR CONTINUES TO PROVIDE VENTILATORY SUPPORT TO THE PATIENT USING AN AIR GAS SOURCE. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PATIENT. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. THE MANUFACTURERS SERVICE ENGINEER REPLACED THE DATA ACQUISITION PCB BOARD AND OXYGEN SOLENOID VALVE TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620847 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown