BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3892640 · Received June 24, 2014

    Report

    Report Number
    2031642-2014-00546
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE UNIT WAS TURNED ON. THE UNIT KEEPS BEEPING AND THE SCREEN IS BLANK. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER SPOKE TO TECH SUPPORT AND ADVISED HIM TO UNPLUGGED THE BATTERY AND TRY A DIFFERENT BATTERY AND IF THE UNIT STILL BEEPING AND NOT POWERING UP, TECH SUPPORT SAID THAT IT COULD BE THE PM BOARD. THE CUSTOMER UNPLUGGED THE BATTERY AND RECONNECTED IT BACKUP AND THE UNIT STOPS BEEPING AND THE UNIT POWERED UP. THE CUSTOMER SAID THAT NO PARTS WAS REPLACED AND THE UNIT IS NOW WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369242 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1