BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 9511760 · Received December 23, 2019

    Report

    Report Number
    2031642-2019-10937
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Report Date
    December 6, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 23DEC2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH INTERNAL OXYGEN (O2) REFERENCING CODES FLOW ERROR, AND EXHALATION (EXH) FLOW ACCURACY. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED HIGH INTERNAL O2 ISSUE CODES FLOW ERROR, AND EXH FLOW ACCURACY ERROR. THE FSE REPLACED THE FAN, AIR INTAKE, PRINTED CIRCUIT BOARD ASSEMBLY, VIDEO GRAPHICS ASSEMBLY CONTROLLER, AND THE AIR/EXHALATION FLOW SENSOR. PERFORMANCE VERIFICATION TEST PASSED FOLLOWING REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308764 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1