inforMED
InjuryCAF

PACIFICA ELITE NEBULIZER - DRIVEMEDICAL

Received Sep 3, 2025 · Event occurred Aug 27, 2025

Report MW5175591 · MDR key 22955718

Device

Generic name

Nebulizer (direct Patient Interface)

Model number

NEB KIT 500 18070

Product problems

  • Leak/Splash

Patient

77 YR · Female

  • Asthma
  • Pleural Effusion
  • Pulmonary Edema
  • Cough
  • Hyponatremia
  • Asthma
  • Pleural Effusion
  • Pulmonary Edema
  • Cough
  • Hyponatremia

Narrative

Description of Event or Problem

I WAS USING A NEW NEBULIZER, PACIFICA ELITE NEBULIZER, PRESUMABLY TO INHALE MEDICATION FOR VARYING DIAGNOSES INCLUDING MUCOID CYSTS. THE NEBULIZER CORD IS EXTREMELY LONG & RETAINS SIGNIFICANT WATER DROPLETS. SOME OF THESE GOT IN MY LUNGS. THE MECHANISM MAY ALSO CONTAIN WATER DROPLETS, AS IT LEAKS AT THE TUBING ENTRANCE. I HAVE CALLED MY PULMONOLOGIST AND MY PHARMACY. MY PULMONOLOGIST WILL CALL IN A NEW PRESCRIPTION FOR A DIFFERENT BRAND OF NEBULIZER AND THE PHARMACIST HAS NOTED NOT TO ACCEPT (B)(6) NEBULIZER. MY TREATMENT HAS BEEN SLOWED, I HAVE DEVELOPED A PAINFUL COUGH WITH SOME BLOOD AND MY BREATHING IS MORE DIFFICULT THAN BEFORE. I AM ON AN ANTIBIOTIC WHICH HOPEFULLY WILL PREVENT ANY FURTHER INFECTION. I HAVE SPENT WEEKS ON ANTIBIOTICS AND AM IN LONG COVID AS WELL ASTHMATIC. THESE LUNG GROWTHS ARE POST COVID. (B)(6). I HAVE HAD NUMEROUS CT SINCE (B)(6) 2025 WITH DIAGNOSES VARY FROM NON-CONTAGIOUS TUBERCULOSIS, MAC AND MUCOID CYSTS. I AM HYPONATREMIC & THE INHALANT MEDICATION WAS SALINE IN AN ATTEMPT TO LOOSEN THE 'CYSTS' I DID NOT NEED TO BE INHALING WATER WHICH IN MY CASE IS RESTRICTED DUE TO HYPONATREMIA. OF COURSE, WATER DOES NOT BELONG IN THE LUNGS. PLEASE ACCEPT THIS REPORT. I HAVE ENTERED THE INFORMATION THAT I HAVE. (B)(6).