87FRN HOSPIRA, INC.

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. (B) (4)

THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING. DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "BROKEN." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.