THE VEST APX SYSTEM

Additional Manufacturer Narrative

THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE DEVICE REMAINS WITH THE PATIENT FOR CONTINUED USE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE VEST AIRWAY CLEARANCE SYSTEM IS INTENDED TO HELP PROVIDE EFFECTIVE AIRWAY CLEARANCE. THE UNIT HAS AN INFLATABLE VEST GARMENT ATTACHED BY AIR HOSES TO AN AIR PULSE GENERATOR. THE AIR PULSE GENERATOR RAPIDLY INFLATED AND DEFLATES THE INFLATABLE VEST TO GENTLY COMPRESS AND RELEASE THE CHEST WALL, CREATING AIRFLOW WITHIN THE LUNGS. THIS PROCESS, MIMICS COUGHING, MOVES MUCUS TOWARD THE PARGE AIRWAYS WHERE IT CAN BE CLEARED BY COUGHING OR SUCTIONING. A SEARCH OF THE BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS PRODUCT. IT IS UNKNOWN IF THE CUSTOMER PERFORMS PREVENTATIVE MAINTENANCE ON THEIR PRODUCTS.

Description of Event or Problem

IT WAS REPORTED THAT AFTER COMPLETED VEST APX DEVICE TREATMENT PATIENT BELIEVE THAT THE SHAKING LOOSENED A PRE-EXISTING KIDNEY STONE. THE PATIENT STARTED THE VEST APX THERAPY IN (B)(6) 2026 AND AFTER A FEW TREATMENTS THE PATIENT WAS HOSPITALIZED IN THE SAME MONTH AND IT WAS CONFIRMED BY COMPUTED TOMOGRAPHY SCAN THAT THE PATIENT HAD A KIDNEY STONE. THE PATIENT UNDERWENT PLACEMENT OF A URETERAL STENT. AFTER THIS INCIDENT, THE PATIENT'S PULMONOLOGIST ADVISED TO CONTINUE USING THE DEVICE TWO TIMES PER DAY. THE PATIENT RESUMED THERAPY IN (B)(6) 2026 AND DID NOT EXPERIENCE ANY FURTHER COMPLICATIONS. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE DEVICE REMAINS WITH THE PATIENT FOR CONTINUED USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.