F&P NEOPUFF

Additional Manufacturer Narrative

(B)(6). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

Description of Event or Problem

A HEALTHCARE FACILITY IN TEXAS REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(4). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CALIFORNIA WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: UPON EVALUATION OF THE PHOTOGRAPHY PROVIDED AND REVIEW OF SERVICE REPORT, IT WAS OBSERVED THAT THE GAS OUTLET PORT OF THE SUBJECT DEVICE WAS BROKEN CONCLUSION: WE COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. AS PART OF MANUFACTURING PROCESS, EACH NEOPUFF UNIT UNDERGOES 100% TESTING ON THE PRODUCTION LINE TO ENSURE COMPLIANCE WITH CRITICAL PRODUCT SPECIFICATIONS. UNITS THAT DO NOT MEET THE SPECIFICATIONS ARE REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION. THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. IN ADDITION, THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". AS MENTIONED, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT.

Description of Event or Problem

A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.