BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 2862868 · Received December 10, 2012

    Report

    Report Number
    2031642-2012-00527
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 30, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. EVALUATION OF THE VENTILATOR DIAGNOSTIC LOG BY THE CUSTOMER NOTED A POWER FAIL OCCURRENCE. THE CSS ADVISED THE CUSTOMER REPLACEMENT OF POWER SUPPLY TO ADDRESS THE REPORTED VENT INOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1