BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2962378 · Received February 14, 2013

    Report

    Report Number
    2031642-2013-00073
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING AND HAD NO DISPLAY. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE, WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DIAGNOSTIC LOG DURING SERVICE NOTED VOLTAGE FAILURE OCCURRENCES WHICH MAY RESULT IN A SHUT DOWN OF THE DEVICE WITH ALARM DURING OPERATION. THE SERVICE TECHNICIAN REPLACED THE CPU PCB BOARD TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64589 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1