BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVV VENTILATOR

    MDR report key: 260613 · Received February 1, 2000

    Report

    Report Number
    2518422-2000-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2000
    Date of Event
    January 25, 2000
    Report Date
    January 28, 2000
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT CAME IN AS AN EXCHANGE FOR PT COMFORT. THERE WAS NO REPORTED PROBLEM. IN THE REPAIR EVAL, AN INTERMITTENT ALARM FAILURE WAS DISCOVERED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVV VENTILATOR CONTINUOUS VENTILATOR CBK RESPIRONICS, INC. 33001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA