BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8708261 · Received June 18, 2019

    Report

    Report Number
    2031642-2019-03901
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    June 7, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 18JUNE2019. THE CUSTOMER'S BIOMED CONFIRMED THE REPORTED PRESSURE ISSUE. THE BIOMED FOUND THAT THE MATING SURFACE WAS SLIGHTLY CONCAVE AND NOT MAKING A GOOD SEAL. THE CUSTOMER'S BIOMED INSTALLED A NEW HEATED BACTERIA FILTER AND UNIT NOW PASSED THE EST PRV TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE EXTENDED SELF TEST (EST) THE UNIT FAILED THE PRESSURE RELIEF VALVE (PRV), WAS NOT BUILDING ENOUGH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503986 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1