BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2080666 · Received May 6, 2011

    Report

    Report Number
    2031642-2011-00142
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 11, 2011
    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

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING OPERATION. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ONLY ABLE TO DUPLICATE A VENT INOP OCCURRENCE DUE TO PRESSURE REGULATION HIGH DURING TESTING WHEN USING THE CUSTOMERS PATIENT CIRCUIT AND BACTERIA FILTER ATTACHED. APPLICABLE TESTING WAS PERFORMED AND TESTS PASSED TO OPERATING SPECIFICATIONS. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1