BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 9795420 · Received March 5, 2020

    Report

    Report Number
    2031642-2020-00801
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Report Date
    February 17, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 05MAR2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S PRESSURE RELIEF VALVE (PRV) WAS NOT PASSING. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER TROUBLESHOT WITH TECHNICAL SUPPORT AND FOUND THAT THE HEATED FILTER WAS LEAKING. THE CUSTOMER RESEATED THE PRV KIT AND REPLACED THE HEATED FILTER AND CORRECTED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258952 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1