BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102

    MDR report key: 3201541 · Received June 26, 2013

    Report

    Report Number
    2518422-2013-01319
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR ALARMED AND OPERATION STOPPED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED BY THE MFR. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A F/U REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290582 PLV-102 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 37006

    Patients

    Seq Age Sex Outcome Treatment
    1