FDA Adverse Event
Malfunction
Summary report: N
F&P NEOPUFF
MDR report key: 24646463
·
Received March 19, 2026
Report
- Report Number
- 9611451-2026-01013
- Event Type
- Malfunction
- Date Received
- March 19, 2026
- Report Date
- March 20, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). SECTION G4: THE RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, RD900AEU NEOPUFF INFANT RESUSCITATOR IS SOLD IN THE USA. THEREFORE, THE 510(K) NUMBER FOR RD900AEU IS K971695. 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 · 0
A HEALTHCARE FACILITY IN ITALY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE GAS OUTLET PORT OF A RD900ALU NEOPUFF INFANT RESUSCITATOR IS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707082 | F&P NEOPUFF | NEOPUFF INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900ALU | 141126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |