THE VEST APX SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO WAS USING THE VEST AIRWAY CLEARANCE SYSTEM WAS HOSPITALIZED FOR PNEUMONIA AND TREATED WITH NEBULIZER THERAPY, ANTIBIOTIC THERAPY, STEROID MEDICATION, AND BRONCHOSCOPY.PRIOR TO THE PNEUMONIA HOSPITALIZATION, THE PATIENT REPORTED BACK PAIN ASSOCIATED WITH DEVICE USE AND SOUGHT EMERGENCY MEDICAL EVALUATION. DURING THE SECOND HOSPITALIZATION FOR PNEUMONIA, PATIENT RECEIVED NEBULIZERS, ANTIBIOTICS, STEROIDS, AND UNDERWENT BRONCHOSCOPY. THE PATIENT REPORTED THAT THE BACK PAIN HAS RESOLVED AND STATED THAT A NEW PULMONOLOGIST HAS MANAGED THE PATIENT¿S CONDITION WITH MEDICATION. THE PATIENT ELECTED TO DISCONTINUE USE OF THE DEVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.