MalfunctionFMT
F&P NEOPUFF
Received May 26, 2026
Report 9611451-2026-01772 · MDR key 25291174
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2101017078
Product problems
- Pressure Problem
Patient
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 VENDOR IN WASHINGTON REPORTED, ON BEHALF OF A HEALTHCARE FACILITY, THAT DURING PREVENTIVE MAINTENANCE OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR, THE PEAK INSPIRATORY PRESSURE COULD NOT BE ADJUSTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.