FDA Adverse Event
Malfunction
Summary report: N
F&P NEOPUFF
MDR report key: 24754330
·
Received April 1, 2026
Report
- Report Number
- 9611451-2026-01070
- Event Type
- Malfunction
- Date Received
- April 1, 2026
- Report Date
- April 1, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). SECTION G4: THE RD900AFU 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. 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 FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE VALUES OBSERVED IN A RD900AEU NEOPUFF INFANT RESUSCITATOR ARE OUTSIDE ACCEPTABLE TOLERANCE. THERE ARE NO REPORTED PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818365 | F&P NEOPUFF | INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AFU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |