MalfunctionFMT
F&P NEOPUFF
Received Jul 5, 2026
Report 9611451-2026-02108 · MDR key 25713115
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AFUCatalog number
RD900AFU
Lot number
021217
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN FRANCE HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE USER CONTROL OF A RD900AFU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
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.