BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4100197 · Received September 18, 2014

    Report

    Report Number
    2031642-2014-01068
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 28, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR COULD NOT BOOT UP VIA AC POWER. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE PROVIDER CONFIRMED THE REPORTED PROBLEM. DURING EVALUATION, THE SERVICE PROVIDER REPORTED THE UNIT WOULD BOOT UP ON BATTERY POWER, AND THE MAINS POWER LED WAS NOT LIT. THE SERVICE PROVIDER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. FINAL TESTING WAS PERFORMED AND THE UNIT WAS REPORTED FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577612 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1