BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6051581 · Received October 24, 2016

    Report

    Report Number
    2031642-2016-02849
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Report Date
    September 28, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THE POWER MANAGEMENT BOARD WAS RETURNED TO THE MANUFACTURER FOR FAILURE INVESTIGATION. VISUAL INSPECTION OF POWER MANAGEMENT (PM) PCBA REVEALED EVIDENCE OF C258 BURN DAMAGE AND TRACES BURN DAMAGE. FAILURE INVESTIGATION DETERMINED THAT THE C258 BURN DAMAGE AND C258 TRACE TO U50 PIN1 OPEN DAMAGE ON THE POWER MANAGEMENT BOARD PREVENTED THE VENTILATOR FROM POWERING ON.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701883 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1