BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4093680 · Received September 16, 2014

    Report

    Report Number
    2031642-2014-01049
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE. OUT OF WARRANTY; NO REQUEST FOR MNF SERV.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED DUE TO A VENT INOP DATA ACQUISITION PCBA ADC REFERENCE FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM.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. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT ENGINEER (PSE) FOR ASSISTANCE. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE THE DATA ACQUISITION PCB BOARD OR POWER MANAGEMENT PCB BOARD FOR THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE DATA ACQUISITION PCB BOARD WAS REPLACED AND THE REPORTED PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573375 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1