MalfunctionFMT
F&P NEOPUFF
Received Jun 5, 2026
Report 9611451-2026-01809 · MDR key 25406732
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2100593326
Product problems
- Break
Patient
NA · Unknown
- 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.
Description of Event or Problem
A DISTRIBUTOR IN TEXAS REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE GAS INLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.