BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8962205 · Received September 4, 2019

    Report

    Report Number
    2031642-2019-08034
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    July 25, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 09/04/2019. THE SERVICE ENGINEER REPLACED THE AIR EXHALATION FLOW SENSOR AND THE SENSOR PCBA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GAS ACCURACY FAILED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756761 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1