BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3822183 · Received May 20, 2014

    Report

    Report Number
    2031642-2014-00364
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    December 6, 2024
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DUE TO A DATA ACQUISITION PCB ADC REFERENCE FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE , BUT NO PATIENT HARM. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE MANUFACTURER SERVICE TECHNICIAN COULD NOT DUPLICATE THE REPORTED PROBLEM. THE MANUFACTURER SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION CABLE TO MOTOR CONTROLLER BOARD AS A PRECAUTIONARY MEASURE. APPLICABLE TESTING WAS PERFORMED AND THE UNIT PASSED ALL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299342 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown