F&P NEOPUFF
Received Mar 24, 2026
Report 9611451-2026-01049 · MDR key 24671766
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2100495019
Product problems
- Pressure Problem
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CALIFORNIA WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: THE SERVICE REPORT WAS REVIEWED, AND IT WAS CONFIRMED THAT THE PEAK INSPIRATORY PRESSURE KNOB WAS STICKING. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE AND CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE.
Description of Event or Problem
A HEALTHCARE FACILITY IN WISCONSIN HAS REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR WOULD NOT MEASURE PEAK PRESSURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Description of Event or Problem
A HEALTHCARE FACILITY IN WISCONSIN HAS REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR WOULD NOT MEASURE PEAK PRESSURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
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.