ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. E1: TELEPHONE- (B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE SURGERY THE DEVICE IS LEAKING AIR NEAR THE CONNECTOR. NO INFO ON PATIENT IMPACT PROVIDED. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS NOTED.