BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3211722 · Received July 8, 2013

    Report

    Report Number
    2031642-2013-00326
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 26, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG NOTED A DATA ACQUISITION PCBA ADC REFERENCE FAILURE WHICH MAY RESULT IN A VENT INOP OCCURRENCE. 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. UPON EVALUATION, THE MANUFACTURERS SERVICE TECHNICIAN REPORTED THE DATA ACQUISITION PCB BOARD WAS DISPLAYING NO INFORMATION. THE SERVICE TECHNICIAN REPLACED THE CABLE BETWEEN THE DATA ACQUISITION AND MOTOR CONTROLLER BOARD TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312322 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1