FISHER & PAYKEL HEALTHCARE

Description of Event or Problem

A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RD900AZU NEOPUFF INFANT RESUSCITATOR'S GAS INLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

(B)(4). METHOD: THE SUBJECT DEVICE, RD900AZU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CHINA, WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHY CONFIRMED THAT THE INLET PORT WAS BROKEN. CONCLUSION: BASED ON THE VISUAL EVALUATION OF THE PROVIDED PHOTOGRAPHY, AND OUR KNOWLEDGE OF THE PRODUCT, THE REPORTED EVENT WAS LIKELY DUE TO THE PHYSICAL IMPACT. 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 IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, 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. SECTION G4: THE RD900AZU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.

Additional Manufacturer Narrative

(B)(4) 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. SECTION G4: THE RD900AZU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.

Description of Event or Problem

A HEALTHCARE FACILITY IN CHINA REPORTED THAT A RD900AZU NEOPUFF INFANT RESUSCITATOR'S GAS INLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.