BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3241703 · Received July 22, 2013

    Report

    Report Number
    2031642-2013-00356
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 10, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CABLE WAS RESEATED TO JUMPER CONNECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO A PRESSURE SENSOR FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. AS REPORTED, FAILURE OF THE PRESSURE SENSORS MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT, WHICH MAY RESULT IN A VENT INOP OCCURRENCE. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE MANUFACTURERS FIELD SERVICE ENGINEER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. UPON EVALUATION OF THE DEVICE, THE SERVICE ENGINEER REPORTED FINDING THE CABLE FROM THE DATA ACQUISITION PCB BOARD UNSEATED FROM THE JUMPER CONNECTION. THE SERVICE ENGINEER RESEATED THE CONNECTOR ON THE JUMPER TO CORRECT THE FINDING AND ADDRESS THE REPORTED PROBLEM. THE SERVICE ENGINEER ALSO NOTED AN OVERVOLTAGE PROTECTION CIRCUIT FAULT DURING THE SERVICE. THE SERVICE ENGINEER REPLACED THE MOTOR CONTROLLER PCB BOARD TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340645 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1