BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5967679 · Received September 21, 2016

    Report

    Report Number
    2031642-2016-02421
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Report Date
    August 30, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER MANAGEMENT BOARD WAS RETURNED TO THE MANUFACTURER FOR FAILURE INVESTIGATION. VISUAL INSPECTION OF THE POWER MANAGEMENT BOARD (PM PCBA) REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION, DURING DEBUGGING THE FAILURE INVESTIGATOR FOUND Y1 (10 MHZ OSCILLATOR) ON THE PM PCBA WITH NO 10 MHZ CLK OUTPUT SIGNAL AND Q42 (N-CHANNEL LOGIC LEVEL ENHANCEMENT MODE FIELD EFFECT TRANSISTOR) PIN 1 DRAIN TO PIN2 GATE SHORTED. IT WAS DETERMINED THAT THE COMPONENT FAILURE Y1 AND Q42 SHORTED ON THE PM PCBA PREVENTED THE VENTILATOR FROM POWERING ON.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WILL NOT POWER ON EITHER ON AC OR DC POWER. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618024 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1