BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3953732 · Received July 23, 2014

    Report

    Report Number
    2031642-2014-00720
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 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 MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BATTERY WOULD NOT CHARGE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE WAS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. PSE ADVISED THE BIOMEDICAL ENGINEER TO EVALUATE THE POWER MANAGEMENT PCB BOARD FOR REPLACEMENT TO ADDRESS THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER REPORTED THE POWER MANAGEMENT BOARD AND BATTERY WERE REPLACED TO ADDRESS THE REPORTED PROBLEM AND THE DEVICE IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431532 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1