BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2811771 · Received October 31, 2012

    Report

    Report Number
    2031642-2012-00479
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 19, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE. (B)(4): OUT OF WARRANTY; NO REQUEST FOR MNF SERV.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT DUE TO A 12V SUPPLY FAILURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. AS THE DEVICE WAS OUT OF WARRANTY, THE MANUFACTURERS PRODUCT SUPPORT ENGINEER ADVISED THE CUSTOMER TO REPLACE THE POWER MANAGEMENT PCB BOARD TO ADDRESS THE REPORTED PROBLEM. 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.

    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