FISHER & PAYKEL HEALTHCARE

Description of Event or Problem

A HEALTHCARE FACILITY IN OKLAHOMA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE IW930AEU SERVO-CONTROL COSYCOT INFANT WARMER FAILED THE POWER FAILURE ALARM TEST DURING A DEVICE MAINTENANCE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(6). SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. METHOD: THE SUBJECT DEVICE, IW930AEU SERVO-CONTROL COSYCOT INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE SUBJECT DEVICE FAILED THE POWER FAILURE ALARM TEST DURING A DEVICE MAINTENANCE CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE, AND FUNCTIONAL CHECKS - INCLUDING THE POWER FAIL ALARM AT LEAST ONCE A YEAR. INCLUDED IN THE WARMER'S MAINTENANCE CHECKLIST IS A TEST OF THE SUPER CAPACITOR TO ENSURE IT IS OPERATING WITHIN SPECIFICATIONS.