BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4100274 · Received September 18, 2014

    Report

    Report Number
    2031642-2014-01069
    Event Type
    Malfunction
    Date Received
    September 18, 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
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECH REPLACED THE FLOWSENSORS TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND DISPLAYED A PRESSURE SENSOR FAILURE. THE MANUFACTURERS SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE, BUT NO PATIENT HARM REPORTED. IF THE REPORTED PROBLEM OCCURRED WHILE IN USE IN NORMAL VENTILATION MODE OPERATION IT MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT AND MAY RESULT IN THE UNIT GOING VENT INOP. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION THE SERVICE TECH FOUND THAT THE SENSOR RIBBON CABLE BURNED. THE SERVICE TECH REPLACED THE AIR & O2 FLOW SENSOR ASSEMBLY. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579954 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1