FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00925
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Report Date
- March 3, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- UDI-DI
- 09420012410979
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6). 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 RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.
(B)(4). METHOD: THE SUBJECT RD900ALU NEOPUFF INFANT RESUSCITATOR WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHY CONFIRMED THAT THE GAS OUTLET PORT WAS CRACKED. THE HEALTHCARE FACILITY FURTHER REPORTED THAT GIOCLOR SPRAY WAS USED AFTER EACH USE TO CLEAN THE DEVICE AND ALSO THAT THE DEVICE HAD SUSTAINED PHYSICAL IMPACT DUE TO A FALL. CONCLUSION: BASED ON THE VISUAL EVALUATION OF THE PROVIDED PHOTOGRAPHY, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT, THE REPORTED EVENT WAS LIKELY COMBINATION OF PHYSICAL IMPACT AND/OR MECHANICAL STRESS AND/OR CHEMICAL ATTACK. SECTION G4: THE RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.
A DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE GAS INTLET PORT OF AN RD900ALU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
A DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE GAS INTLET PORT OF AN RD900ALU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2430913 | FISHER & PAYKEL HEALTHCARE | NEOPUFF INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AGU | 2100031012 | 09420012410979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |