BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 2555221 · Received May 1, 2012

    Report

    Report Number
    2031642-2012-00202
    Event Type
    Death
    Date Received
    May 1, 2012
    Date of Event
    April 7, 2012
    Report Date
    August 15, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO THE MANUFACTURER THAT THE PATIENT DIED (B)(6) 2012. THE PATIENT HAD BEEN USING THE VENTILATOR FOR DAILY TREATMENT DUE TO CARDIAC DISEASE. THE PATIENT'S DOCTOR REPORTED TO THE VENTILATOR COMPANY SALES TEAM THAT THE PATIENT HAD DIED DUE TO THE CARDIAC DISEASE SYMPTOMS, BUT COULD NOT DRAW A CONCLUSION AS TO WHETHER THE INITIAL REPORTED EVENT CAUSED A NEGATIVE EFFECT TO THE PATIENT'S CARDIAC DISEASE RECOVERY OR NOT, BECAUSE THE PATIENT FAMILY WAS REFUSING AN AUTOPSY. FACTORY ANALYSIS OF THE RETURNED BLOWER FOUND THE FAILURE WAS CAUSED BY THE IMPELLER RUBBING ON THE END CAP.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR ALARMED AND HAD NO FLOW OUTPUT. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. UPON EVALUATION OF THE UNIT THE DEALER REPORTED THAT THE BLOWER WAS BLOCKED. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG NOTED AN OCCLUSION OCCURRENCE. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE BLOWER WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. FAILURE OF THE BLOWER AS NOTED COULD RESULT IN NO VENTILATION DURING NORMAL VENTILATION OPERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death