BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2834515 · Received November 15, 2012

    Report

    Report Number
    2031642-2012-00504
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 28, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC LOG CONFIRMED THE VENT INOP OCCURRENCE. THE MANUFACTURERS SERVICE TECHNICIAN WILL REPLACE THE CPU PCB BOARD TO ADDRESS THE REPORTED PROBLEM. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED.

    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