BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4821346 · Received June 5, 2015

    Report

    Report Number
    2031642-2015-01021
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 27, 2015
    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

    PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER STATED THE PATIENT INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS CONTINUOUSLY ALARMING WHILE IN USE ON A PATIENT. THE UNIT WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS PLACED ON A DIFFERENT UNIT. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364988 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1