F&P NEOPUFF

Description of Event or Problem

A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB AND THE PEAK INSPIRATORY PRESSURE KNOB OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR ARE NOT ROTATING SMOOTHLY. IT WAS FURTHER REPORTED THAT 12 OTHER UNITS WERE AFFECTED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(4). SECTION D4: ADDITIONAL UDI DETAILS FOR THE RD900AEU NEOPUFF INFANT RESUSCITATOR: (B)(4). 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.