BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4163500 · Received October 10, 2014

    Report

    Report Number
    2031642-2014-01188
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO MANUFACTURER SERVICE REQUEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. A DATA ACQUISITION PCBA ADC REFERENCE FAILURE DURING NORMAL VENTILATION OPERATION MAY RESULT IN A VENT INOP CONDITION. A VENT INOP 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 CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT , BUT NO PATIENT HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT ENGINEER (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER COULD NOT DUPLICATE THE REPORTED PROBLEM. THE PSE SUGGESTED TO BIOMEDICAL ENGINEER TO PERFORMED SUCCESSFUL PVT BEFORE PLACING UNIT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640573 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1