BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2772252 · Received October 4, 2012

    Report

    Report Number
    2031642-2012-00438
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 25, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SHUT DOWN WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THE DEVICE HAD AN OVERHEATING ODOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURERS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT PCB BOARD AS A PRECAUTION. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    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