FDA Adverse Event
Malfunction
Summary report: N
F&P NEOPUFF
MDR report key: 25155890
·
Received May 12, 2026
Report
- Report Number
- 9611451-2026-01656
- Event Type
- Malfunction
- Date Received
- May 12, 2026
- Report Date
- May 13, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- UDI-DI
- 09420012411006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(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. SECTION G4: THE RD900AUU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.
Description of Event or Problem · 0
A HEALTHCARE FACILITY IN ARGENTINA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE MANOMETER NEEDLE OF A RD900ASU NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 70CMH2O WITHOUT BEING CONNECTED TO A GAS SOURCE AND WHEN THE DEVICE WAS CONNECTED TO A GAS SOURCE THE NEEDLE BARELY MOVED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543725 | F&P NEOPUFF | NEOPUFF INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900ASU | 2104068396 | 09420012411006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |