AMBU SPUR II ADULT RESUSCITATOR

Additional Manufacturer Narrative

THE SUSPECTED FAILURE WAS DETECTED DURING THE USE OF THE RESUSCITATOR. NEITHER A SAMPLE OR A PICTURE WAS RECEIVED TO EVALUATE SUSPECTED FAILURE. THE REPORTED PRODUCT WAS MANUFACTURED AND CONTROLLED IN ACCORDANCE WITH THE WORKING INSTRUCTIONS. 100% FUNCTION TEST AFTER ASSEMBLY AND 100% VISUAL INSPECTION IS CONDUCTED ON ALL SPUR II DEVICES BEFORE BEING DELIVERED TO USER. THE INCIDENT SHOULD NOT BE POSSIBLE WHEN THE INSTRUCTIONS FOR USE IS FOLLOWED CORRECTLY. THE RESUSCITATOR IS DESIGNED SO THAT THE OUTLET CONNECTOR CAN BE SCREWED OFF AND THE PATIENT VALVE CAN BE CLEANED. IT IS MOST LIKELY THAT THE RESUSCITATOR WAS NOT PROPERLY REASSEMBLED AFTER SUCH CLEANING. DUE TO THE LIMITED INFORMATION AVAILABLE A ROOT CAUSE CANNOT BE IDENTIFIED. THE COMPLAINT RATE IS ASSESSED TO BE ACCEPTABLY LOW DURING THE LAST 12 MONTHS AND CUSTOMER HAS CHECKED ALL OTHER STOCKS IN THE HOSPITAL AND DID NOT SEE MORE LIKE THIS. ACCORDING TO THE INSTRUCTIONS FOR USE THE DESCRIBED FAILURE CAN EASILY BE DETECTED DURING PRECHECK. IT SEEMS MOST LIKELY TO BE CAUSED BY USER MISHANDLING. SINCE NO DESIGN OR MANUFACTURING PROBLEM IS IDENTIFIED, CORRECTIVE ACTIONS IS NOT REQUIRED. DEVICE WAS REQUESTED, IF DEVICE RETURNED FOR INVESTIGATION, AND NEW INFORMATION WARRANTED, WE WILL SUBMIT FOLLOW UP REPORT. AMBU WILL KEEP MONITORING THIS ISSUE AND TAKE ACTIONS IF NECESSARY.

Description of Event or Problem

THE CUSTOMER HAS REPORTED THAT A FLUTTER VALVE WAS MISSING FROM A SPUR II. THE PATIENT ON WHICH THE PRODUCT WAS USED UNFORTUNATELY DIED.