BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3983614 · Received July 9, 2014

    Report

    Report Number
    2031642-2014-00649
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY REPAIR: NO REQUEST FOR SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VENTILATOR ALARMED WITH PRESSURE SENSORS FAILURE AND CALIBRATION ERRORS. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PT AND THERE WAS NO PT HARM. PER BIOMED HE COULD NOT DUPLICATE THE REPORTED PROBLEM, BUT SAID THAT REVIEW OF THE DEVICE DIAGNOSTIC CODES INDICATED A FAILURE OF THE INTERNAL COMMUNICATION LINK BETWEEN CPU AND GAS DELIVERY SYSTEM, WHICH MAY RESULT IN A VENT INOP CONDITION. A VENT INOP DURING NORMAL VENTILATION 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 BIOMED REPLACED THE DATA ACQUISITION BOARD AND DATA ACQUISITION TO MOTOR CONTROLLER CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402191 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1