BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5233842 · Received November 18, 2015

    Report

    Report Number
    2031642-2015-02410
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Report Date
    October 29, 2015
    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

    THE MANUFACTURER'S FIELD SERVICE ENGINEER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE MANUFACTURER'S FIELD SERVICE ENGINEER REPAIRED THE UNIT BY REPLACING THE POWER SUPPLY AND MOTOR CONTROLLER BOARD. ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR TURNS OFF. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762256 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1