AIRWAY PRESSURE MONITOR

Description of Event or Problem

INFO WAS RECEIVED REGARDING AN ALLEGATION THAT MEDICAL EQUIPMENT SUPPLIED TO A PT WAS DEFECTIVELY PROVIDED AND/OR MAINTAINED AND OTHERWISE MALFUNCTIONED AND/OR BECAME INOPERATIVE WHILE IN PT USE. THE ALLEGED PROBLEM WITH THE EQUIPMENT OCCURRED PROXIMATELY CAUSING THE DEATH OF THE PT TWO DAYS LATER. IT IS UNCLEAR WHICH OF THE PRODUCTS ALLEGEDLY MALFUNCTIONED. IT IS UNCLEAR IF THE EQUIPMENT WAS IN PT USE AT THE TIME OF DEATH. THE EQUIPMENT IS NOT CURRENTLY AVAILABLE FOR INVESTIGATION. THE ALARM SETTINGS AT THE TIME OF THE ALLEGED MALFUNCTION ARE UNK. IT IS UNK AT THIS TIME WHETHER A DEVICE FAILURE HAD ACTUALLY OCCURRED AND IF SO, WHETHER THERE WAS ANY ASSOCIATION BETWEEN ANY SUCH FAILURE AND THE PT EXPIRING.