BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 2933374 · Received January 29, 2013

    Report

    Report Number
    2031642-2013-00042
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 16, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING AND DELIVERING RANDOM BREATHS WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED INITIAL TESTING OF THE SINGLE PATIENT USE (SPU) EXPIRATORY FILTER IN USE ON THE VENTILATOR FAILED DUE TO THE PRESSURE BEING OUT OF SPECIFICATION AT (B)(4), WHICH INDICATES AN OCCLUSION. WHEN AN OCCLUSION IS DETECTED DURING NORMAL VENTILATION, THE VENTILATOR WILL OPEN THE SAFETY VALVE WHICH ALLOWS THE PATIENT TO BREATHE THROUGH THE SYSTEM. WHEN THE SAFETY VALVE IS OPEN IT IS ACCOMPANIED BY AN ALARM AND A MESSAGE IN THE DISPLAY. THE SERVICE TECHNICIAN REPLACED THE CUSTOMERS EXHALATION FILTER AND TESTING PASSED. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS. FILTER MAINTENANCE MUST BE PERFORMED PER MANUFACTURER RECOMMENDATIONS AND SPECIFIED INTERVALS. THERE WAS NO MALFUNCTION OF THE DEVICE OR THE SAFETY VALVE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39446 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1