BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3222690 · Received July 12, 2013

    Report

    Report Number
    2031642-2013-00335
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 28, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LOCKING TAB OF CABLE NOT LOCKED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS POWERED ON FOR PREVENTIVE MAINTENANCE SERVICE AND ALARMED DURING POWER ON SELF TEST (POST) DUE TO A PRESSURE SENSOR FAILURE. THE MANUFACTURERS SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DEVICE DIAGNOSTIC LOG VERIFIED PROXIMAL AND MACHINE PRESSURE SENSOR AUTOZEROING FAILED. AS NOTED, 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. DURING EVALUATION, THE SERVICE TECHNICIAN REPORTED THE LOCKING TAB OF THE CABLE BETWEEN THE DATA ACQUISITION AND MOTOR CONTROLLER PCB BOARDS WAS NOT FULLY LOCKED. THE SERVICE TECHNICIAN RESEATED THE CABLE TO LOCK IT AND REPORTED THE DEVICE SUCCESSFULLY POWERED THROUGH POST. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321920 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1