FISHER & PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(4). SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. METHOD: THE SUBJECT DEVICE, IW990AGU WALL MOUNT 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 IW990AGU WALL MOUNT INFANT WARMER WAS DISPLAYING AN ERROR CODE 17. CONCLUSION: THE REPORTED EVENT MOST LIKELY OCCURRED DUE TO THE HEATING ELEMENT BEING OPEN CIRCUIT, WHICH COULD RESULT FROM AGING OF THE HEATING ELEMENT PARTS. THE USER MANUAL FOR THE IW990 INFANT WARMER STATES THE FOLLOWING: - "ENSURE ALL WARMER PARTS AND ACCESSORIES ARE CHECKED BEFORE RETURNING THE DEVICE TO SERVICE." ADDITIONALLY, THE DEVICE TECHNICAL/SERVICE MANUAL OF THE IW990 INFANT WARMER CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE, AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR.

Description of Event or Problem

A HEALTHCARE FACILITY IN GERMANY REPORTED THAT THE IW990AGU WALL MOUNT INFANT WARMER IS DISPLAYING AN ERROR CODE 17. THERE WAS NO REPORTED PATIENT INVOLVEMENT.