BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8506832 · Received April 11, 2019

    Report

    Report Number
    2031642-2019-02191
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Report Date
    March 21, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 11APR2019. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE MAN-MACHINE INTERFACE (MMI) BOARD TO ADDRESS THE ISSUE AND THE VENTILATOR WAS RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATORS TOUCH SCREEN WAS NOT SENSITIVE. NO PATIENT INVOLVEMENT. EVENT DATE NOT SPECIFIED, ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300432 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1