Description of Event or Problem · 0
PATIENT WAS ISSUED A NOX MEDICAL, NOXT3 HOME SLEEP TEST UNIT FOR DIAGNOSTIC TESTING OF SLEEP APNEA. A COMPONENT OF THE HOME SLEEP DEVICE IS A PULSE OX THAT IS WORN ON THE WRIST THROUGHOUT THE NIGHT. THE PATIENT WORE THE HOME SLEEP TEST UNIT AS DIRECTED BY MANUFACTURER INSTRUCTIONS. WHEN HE TOOK OFF THE PULSE OX FROM HIS LEFT WRIST THE NEXT MORNING HE NOTED A WOUND ON THE PART OF THE SKIN THAT WAS COVERED BY THE PULSE OX UNIT ITSELF. THERE WAS A DEFINITIVE AREA OF SKIN IRRITATION WITH WHITE RESIDUE ON THE OUTLYING AREA OF SKIN. THE WOUND APPEARED TO BE A POSSIBLE SKIN BURN RELATED TO THE BATTERY IN THE PULSE OX UNIT. THE PATIENT WAS SEEN AT A LOCAL ED DEPARTMENT AND THE PHYSICIAN NOTED THE WOUND TO BE A RASH. FOLLOWING THE EVENT, THE UNIT WAS ASSESSED BY THE SLEEP TECHNICIAN. THE BATTERIES IN THE PULSE OX UNIT WERE NOTED TO HAVE EROSION WITH BATTERY ACID LEAKAGE BOTH INSIDE AND OUTSIDE THE BATTERY CAVITY. THE DEVICE HAD NEW BATTERIES PLACED JUST PRIOR TO ISSUING TO THE PATIENT ON (B)(6) 2021. THE DEVICE WAS REMOVED FROM CIRCULATION FOLLOWING THE INCIDENT. BIOMED ASSESSED THE UNIT FOR DAMAGE. THE UNIT WAS SENT TO THE MANUFACTURER.