BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRWAY PRESSURE MONITOR

    MDR report key: 573615 · Received February 17, 2005

    Report

    Report Number
    2518422-2005-00012
    Event Type
    Death
    Date Received
    February 17, 2005
    Date of Event
    November 16, 2003
    Report Date
    January 18, 2005
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT A PT EXPIRED WHILE USING THE DEVICE. REPORT ALLEGED THAT THE PT'S FAMILY MEMBER WAS AWAKENED BY A CHANGE IN THE SOUND OF THE CONCOMITANT DEVICE AND THAT NO ALARM REPORTEDLY SOUNDED. THE REPORT ALLEGES THAT THE PT WAS DISCOVERED TO BE NOT BREATHING AND WAS LATER PRONOUNCED DEAD. DESPITE ATTEMPTS TO OBTAIN ADDITIONAL INFO, NONE HAS BEEN MADE AVAILABLE. ADDITIONAL PT HISTORY AND A COPY OF THE CORONER'S REPORT ARE UNK. THE EQUIPMENT AND ALARM SETTINGS AT THE TIME OF THE EVENT ARE UNK. AN EVAL OF THE UNIT HAS NOT BEEN PERFORMED AT THIS TIME AND EFFORTS TO OBTAIN THE EQUIPMENT HAVE BEEN UNSUCCESSFUL. IT IS UNK AT THIS TIME WHETHER A DEVICE FAILURE HAD ACTUALLY OCCURRED, AND WHETHER THERE WAS ANY ASSOCIATION BETWEEN THE USE OF THE DEVICE AND THE PT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR MONITOR, AIRWAY PRESSURE CAP RESPIRONICS, INC. 332259 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death RESPIRONICS BIPAP S/T D.