FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00813
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Report Date
- October 3, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(6). SECTION G4: THE RD900AWU 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.
(B)(4). SECTION G4: THE RD900AWU 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. METHOD: THE SUBJECT DEVICE, RD900AWU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN FRANCE 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. THE SERVICE CENTRE ALSO REPORTED THAT THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. RESULTS: A REVIEW OF THE SERVICE FINDINGS REVEALED THAT THE MANOMETER WAS FOUND TO BE FAULTY. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. AS PART OF OUR MANUFACTURING PROCESS, EACH NEOPUFF UNIT UNDERGOES 100% TESTING ON THE PRODUCTION LINE TO ENSURE COMPLIANCE WITH CRITICAL PRODUCT SPECIFICATIONS. UNITS THAT DO NOT MEET THE SPECIFICATIONS ARE REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. IN ADDITION, THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". AS MENTIONED, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: - DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT.
A HEALTHCARE FACILITY IN SWEDEN HAS REPORTED THAT THE PRESSURE INDICATED ON THE MANOMETER OF A RD900AWU NEOPUFF INFANT RESUSCITATOR FLUCTUATES BETWEEN 60 AND 65 CMH2O, WHEN BEING SET AT 60CMH2O. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN SWEDEN HAS REPORTED THAT THE PRESSURE INDICATED ON THE MANOMETER OF A RD900AWU NEOPUFF INFANT RESUSCITATOR FLUCTUATES BETWEEN 60 AND 65 CMH2O, WHEN BEING SET AT 60CMH2O. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1828279 | FISHER & PAYKEL HEALTHCARE | INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AWU | 2101418302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |