MalfunctionFMT
F&P NEOPUFF
Received Apr 16, 2026
Report 9611451-2026-01296 · MDR key 24892388
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2103895561
Product problems
- Pressure Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(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.
Description of Event or Problem
A DISTRIBUTOR IN INDIA HAS REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE NEEDLE ON THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR IS NOT MAINTAING PRESSURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.