MalfunctionFMT
F&P NEOPUFF
Received Apr 23, 2026
Report 9611451-2026-01405 · MDR key 24975072
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2103820513
Product problems
- Break
Patient
NA · Unknown
- 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 HEALTHCARE FACILITY IN MASSACHUSETTS REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN.