BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4221121 · Received November 3, 2014

    Report

    Report Number
    2031642-2014-01340
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    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 AND THERE WAS NO PATIENT HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE THE DATA ACQUISITION PCB BOARD AND THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB BOARD CABLE CONNECTIONS FOR THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE PCB BOARD AND THE CABLE WERE RESEATED AND THE UNIT WAS TESTED AND OPERATED WITH NO REPEAT OF THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703198 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1