FISHER & PAYKEL HEALTHCARE

Additional Manufacturer Narrative

(B)(4). METHOD: THE SUBJECT RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, INCLUDING A PHOTOGRAPH, AND OUR KNOWLEDGE OF OUR PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHY HAS REVEALED THAT THE MANIFOLD PORT ON THE MANOMETER TUBE SIDE WAS BROKEN. CONCLUSION: WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. G4: RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FOR RD900 NEOPUFF AND THE 510(K) FOR THE NEOPUFF IS K971695. SECTION D4: DEVICE DETAILS WERE NOT RECEIVED FROM CUSTOMER. SECTION H4: DEVICE MANUFACTURER DATE DETAILS WERE NOT RECEIVED FROM CUSTOMER.

Description of Event or Problem

A DISTRIBUTOR IN UNITED STATES HAS REPORTED THAT THE INTERNAL HOSE OF A RD062 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY BROKE OFF DURING INSTALLATION ON A NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

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. G4: RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FOR RD900 NEOPUFF AND THE THE 510(K) FOR THE NEOPUFF IS K971695. SECTION D4: LOT NUMBER DETAILS WERE NOT RECEIVED FROM CUSTOMER. SECTION D4: UDI DETAILS WERE NOT RECEIVED FROM CUSTOMER. SECTION H4: DEVICE MANUFACTURER DATE DETAILS WERE NOT RECEIVED FROM CUSTOMER.

Description of Event or Problem

A DISTRIBUTOR IN UNITED STATES HAS REPORTED THAT THE INTERNAL HOSE OF A RD062 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY BROKE OFF DURING INSTALLATION ON A NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.