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. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING.

Description of Event or Problem

DURING DEVICE EVALUATION AND PERFORMANCE TESTING OF A RD900AEU NEOPUFF INFANT RESUSCITATOR AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN UNITED STATES, IT WAS FOUND THAT THE MANOMETER WAS GIVING INACCURATE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.