F&P NEOPUFF
Received Jun 25, 2026
Report 9611451-2026-02016 · MDR key 25630448
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900ADUCatalog number
RD900ADU
Lot number
100830
Product problems
- Pressure Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
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. SECTION G4: THE RD900ADU IS NOT SOLD IN THE 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
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED THAT THE NEEDLE OF A RD900ADU NEOPUFF INFANT RESUSCITATOR WAS STICKING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.