BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3230400 · Received July 16, 2013

    Report

    Report Number
    2031642-2013-00193
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    April 11, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MFR'S SERVICE. SERVICE IS IN PROGRESS; RESULTS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNABLE TO REPAIR THE DEVICE, SO MANUFACTURERS SERVICE WAS REQUESTED. THE MANUFACTURERS FIELD SERVICE ENGINEER REPORTED UPON INITIAL INSPECTION THE VENTILATOR WOULD NOT POWER ON AND THE CUSTOMER HAD CHANGED OUT SEVERAL PARTS. THE SERVICE ENGINEER REPLACED THE POWER SUPPLY AND THE DEVICE WAS ABLE TO POWER ON BUT WOULD NOT OPERATE IN NORMAL VENTILATION MODE. THE SERVICE ENGINEER REPLACED THE POWER MANAGEMENT BOARD TO CORRECT THE FINDING. THE SERVICE ENGINEER REPORTED FINAL TESTING PASSED AND THE REPORTED PROBLEM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE POWER MANAGEMENT PCB BOARD REVEALED A COMPONENT FAILURE WHICH, IF IT WERE TO OCCUR DURING OPERATION OF THE DEVICE DURING USE IN NORMAL VENTILATION, A VENT INOPERATIVE CONDITION COULD OCCUR. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. IF IN USE, THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT.

    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 NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS REPORTED, BOTH PRESSURE SENSORS MAY HAVE FAILED WHICH 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. AS THE DEVICE WAS OUT OF WARRANTY, THE BIOMEDICAL ENGINEER CONTACTED MFR'S PRODUCT SUPPORT (PSE) WHO ADVISED EVAL OF THE POWER MANAGEMENT AND MOTOR CONTROLLER PCB BOARDS FOR REPLACEMENT. THE BIOMEDICAL ENGINEER REPORTED HIS EVAL HAS BEEN UNABLE TO ISOLATE THE CAUSE OF THE REPORTED EVENT AND SERVICE IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329168 V60 VENTILATOR VENTILATOR, CONTINUOUS, MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1