FISHER & PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(6). METHOD: THE COMPLAINT IW990AGU WALL MOUNT INFANT WARMER WAS RECEIVED AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN GERMANY WHERE IT WAS VISUALLY INSPECTED AND SERVICED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT IW990AGU WALL MOUNT INFANT WARMER REVEALED THAT THE HEAD WAS DAMAGED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE OBSERVED DAMAGE TO THE IW990 WALL MOUNT INFANT WARMER. THE USER MANUAL FOR THE IW990 INFANT WARMER STATES THE FOLLOWING: - "CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYDROCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE." - "CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES." THE DEVICE TECHNICAL/SERVICE MANUAL ALSO CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE, AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTION G4: THE IW990AGU MANUAL-CONTROL WALL MOUNT INFANT WARMER IS NOT SOLD IN THE UNITED STATES OF AMERICA (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

DURING DEVICE EVALUATION AND PERFORMANCE TESTING OF A IW990AGU WALL MOUNT INFANT WARMER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN (B)(6), IT WAS FOUND THAT THE WARMER HEAD WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.