AIRWAY PRESSURE MONITOR

Description of Event or Problem

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.