HUDSON RCI

Additional Manufacturer Narrative

PER REPORT, "FOR THE PAST COUPLE OF WEEKS, WE HAVE BEEN EXPERIENCING AN ISSUE WHERE PRESSURE IN THE TUBING CAUSES THE NEBULIZER TO DISCONNECT EITHER AT THE FLOWMETER OR FROM THE NEBULIZER CUP." CUSTOMER ALSO REPORTED THAT, "PATIENT WAS RECEIVING A NEBULIZED TREATMENT THROUGH THE HUDSON UP-DRAFT II SMALL VOLUME NEBULIZER. WHILE BEING RAN AT THE RECOMMENDED LITER FLOW, TUBING POPPED OFF FROM THE NEBULIZER, STOPPING THE TREATMENT AND SCARING THE PATIENT." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

PER REPORT, "FOR THE PAST COUPLE OF WEEKS, WE HAVE BEEN EXPERIENCING AN ISSUE WHERE PRESSURE IN THE TUBING CAUSES THE NEBULIZER TO DISCONNECT EITHER AT THE FLOWMETER OR FROM THE NEBULIZER CUP."