BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 3820085 · Received April 2, 2014

    Report

    Report Number
    2518422-2014-00549
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR OVERHEATED AND STOPPED WORKING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200270 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1