BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3881265 · Received June 18, 2014

    Report

    Report Number
    2031642-2014-00505
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURER'S SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD ALARM AND POWER ON AND OFF BY ITSELF. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURER'S PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER REPORTED THE DEVICE WAS OPERATING ON BATTERY POWER AND THOUGHT THE BATTERY DEPLETED. PSE DISCUSSED CHARGING THE BATTERY AND ADVISED COMPLETING PERFORMANCE VERIFICATION TESTING. THE BIOMEDICAL ENGINEER REPORTED THE BATTERY CHARGED AND THE UNIT IS OPERATING WITHOUT FURTHER PROBLEM. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357276 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1