BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3892880 · Received June 24, 2014

    Report

    Report Number
    2031642-2014-00548
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 29, 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

    OUT OF WARRANTY; NO REQUEST FOR MNF SERV.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT TURN ON. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER REPORTED THE VOLTAGES WERE PRESENT AND WITHIN TOLERANCE. PSE ADVISED THE BIOMEDICAL ENGINEER EVALUATE THE POWER MANAGEMENT PCB BOARD. THE BIOMEDICAL ENGINEER REPORTED THE POWER MANAGEMENT PCB BOARD WAS REPLACED AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368536 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1