NEV 100

Description of Event or Problem

INFO WAS RECEIVED THAT THE DEVICE ALLEGEDLY SHUT DOWN AND SOUNDED A BEEPING ALARM WHILE IN PT USE. THE PT WAS FOUND TO BE NON-RESPONSIVE BY THE CAREGIVER, WHO CALLED 911 AND THE PT WAS TRANSFERRED TO A HOSP WHERE HE LATER EXPIRED. ALLEGEDLY, THE AUDIBLE ALARM WAS NOT HEARD BY THE CAREGIVER. THE DURATION BETWEEN WHEN THE DEVICE ALLEGEDLY SHUT DOWN AND WHEN THE CAREGIVER ATTENDED TO THE PT IS UNK. AN AUTOPSY WAS PERFORMED, BUT THE RESULTS WERE NOT RELEASED UPON REQUEST. ALTHOUGH VENTILATOR DEPENDENT, THE PT USED THE DEVICE IN A NON-INVASIVE MANNER ONLY AT NIGHT. ANOTHER DEVICE WAS USED THROUGHOUT THE DAY. IT IS UNK IF ADD'L ALARMS WERE IN USE AT THE TIME OF THE EVENT. THE DEVICE IS IN THE POSSESSSION OF THE COUNTY CORONER AND A REQUEST TO HAVE THE DEVICE RETURNED TO THE MFR FOR EVAL WAS DENIED. THE DEVICE WILL BE EVALUATED BY AN INDEPENDENT THIRD PARTY. IF PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

Additional Manufacturer Narrative

H6: THE DEVICE IS QUARANTINED BY THE CORONER. A REQUEST TO HAVE THE DEVICE RETURNED TO THE MFR FOR EVAL WAS DENIED. THE DEVICE WILL BE EVALUATED BY AN INDEPENDENT THIRD PARTY. H6: NO EVAL HAS BEEN PERFORMED AT THIS TIME.