BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8964659 · Received September 5, 2019

    Report

    Report Number
    2031642-2019-08076
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    February 12, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 09/05/2019. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN ENCOUNTERED ROTARY KNOB NOT WORKING FAILURE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE ROTARY ENCODER TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ROTARY KNOB NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761708 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1