BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4163658 · Received October 10, 2014

    Report

    Report Number
    2031642-2014-01186
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 16, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED AND WOULD NOT OPERATE ON BATTERY POWER. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. POWER FAILURE DUE TO LOSS OF BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION. SPECIFICATIONS. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE, AND REPORTED A NEW BATTERY DID NOT CORRECT THE PROBLEM. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE THE POWER MANAGEMENT PCB BOARD FOR REPLACEMENT TO ADDRESS THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE POWER MANAGEMENT BOARD WAS REPLACED AND THE REPORTED PROBLEM RESOLVED. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639285 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1