NEV-100

Description of Event or Problem

REPORT RECEIVED FROM DISTRIBUTOR THAT A PATIENT HAD EXPIRED AFTER A POWER OUTAGE OCCURRED AT THEIR PLACE OF RESIDENCE. INFORMATION OBTAINED FROM RESPIRATORY THERAPIST IS AS FOLLOWS: THE PT RESIDED AT AN ASSISTED CARE FACILITY WHICH HAD SUFFERED FROM A POWER OUTAGE ON EVENT DATE AROUND 11:30PM. THE PATIENT WAS USING THE DEVICE AT THAT TIME. THE POWER OUTAGE CAUSED THE UNIT TO SHUT DOWN AND SOUND AN ALARM, JUST AS INTENDED. THE PT REPORTEDLY REFUSED TO EXIT THE NU-MO SUIT AND WANTED TO WAIT TILL POWER RETURNED. APPROXIMATELY 10-15 MINUTES HAD PASSED, THE POWER RETURNED BUT THE ELECTRICAL OUTLETS REPORTEDLY WOULD NOT WORK. THE NURSE LEFT THE ROOM TO NOTIFY THE MANAGER AND, IN THE MEANTIME, THE PATIENT'S SPOUSE REPORTED PT STOPPED BREATHING. CPR WAS INITIATED WITHOUT SUCCESS. THERE WERE NO ALLEGED COMPLAINTS WITH THE DEVICE AND RESPIRATORY THERAPIST FELT THE DEVICE RESPONDED APPROPRIATELY. THE PT REPORTEDLY SUFFERED FROM A MASSIVE HEART ATTACK. PER THE MANAGER AT THE DISTRIBUTOR, THE PT DID NOT USE THE DEVICE CONTINUOUSLY.