AMBU SPUR II ADULT BAG RESUSCITATOR

Additional Manufacturer Narrative

DUE TO NO ADDITIONAL FEEDBACK FROM THE CUSTOMER, THE REPORT FAILURE COULD NOT BE IDENTIFIED. INDEED, NEITHER THE SAMPLE NOR THE PICTURE HAS BEEN PROVIDED BY THE CUSTOMER. ACCORDING TO THE INFORMATION RECEIVED, WE COULD UNDERSTAND THAT TWO SPUR II RESUSCITATORS WERE USED IN AN EMERGENCY SITUATION BUT THEY COULD NOT INFLATE PROPERLY. THIS COMPROMISED THE PATIENT´S CONDITION, WHO WAS HYPOXIC AND THE STAFF COULD NOT OXYGENATE THE PATIENT APPROPRIATELY. WE DO NOT KNOW SPECIFIC ISSUES ON TWO AMBU BAGS FROM THE PROVIDED INFORMATION. HOWEVER, DURING THE MANUFACTURING, ALL SPUR II RESUSCITATORS ARE 100% PERFORMED FUNCTION TESTING FOR THE RESERVOIR BAG TO MAKE SURE THE FINISHED PRODUCTS MEET THE DESIGN SPECIFICATION, SO THE RESERVOIR BAG OF SPUR II SHOULD INFLATE TO VENTILATE SUFFICIENT OXYGEN TO THE PATIENT DURING NORMAL USE. DUE TO LIMITED INFORMATION AND NO SAMPLE OR PICTURES, THE SPECIFIC FAILURE AND ROOT CAUSE COULD NOT BE DETERMINED. THIS REPORTED FAILURE COULD BE FOUND BEFORE USING ON PATIENT PER FUNCTION TEST AS STATED IN IFU "ALWAYS INSPECT THE RESUSCITATOR AND PERFORM A FUNCTIONAL TEST AFTER UNPACKING, CLEANING, ASSEMBLY AND PRIOR TO USE". DUE TO LIMITED INFORMATION, SPECIFIC FAILURE AND ROOT CAUSE COULD NOT BE DETERMINED, NO CORRECTIVE ACTIONS AT THIS TIME.

Description of Event or Problem

"TWO FAULTY AMBU BAGS THAT WERE USED IN AN EMERGENT SITUATION LAST EVENING IN THE CVICU. THE RESERVOIR PORTION OF TWO AMBU BAGS WOULD NOT INFLATE. THE AMBU BAGS WERE SEQUESTERED AND ARE BEING SENT TO SECURITY FOR HOLDING." ITEM NUMBER AND LOT NUMBER UNKNOWN, ITEM NUMBER, 520211000, PICKED FOR COMPLAINT FILING PURPOSES ONLY. PATIENT CARE WAS COMPROMISED, "THIS DID COMPROMISE PATIENT CARE AS THE PATIENT WAS HYPOXIC AND THE STAFF WERE UNABLE TO OXYGENATE THE PATIENT APPROPRIATELY DUE TO THE DEFECTIVE AMBU BAGS."