FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2025-00196
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Report Date
- February 3, 2025
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(6). SECTIOND4: SERIAL NUMBERS / LOT NUMBERS: RD900AEU (B)(6) / 100720; RD900AEU (B)(6) / 100720. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTIONH4: DATE OF MANUFACTURING: RD900AEU (B)(6) / 100720: 20-JULY-2010; RD900AEU (B)(6) / 100720: 20-JULY-2010. FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL SUBMIT A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(6). SECTIOND4: SERIAL NUMBERS / LOT NUMBERS: RD900AEU (B)(6)/ 100720, RD900AEU (B)(6)/ 100720. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTIONH4: DATE OF MANUFACTURING: RD900AEU (B)(6)/ 100720: 20-JULY-2010, RD900AEU (B)(6)/ 100720: 20-JULY-2010. METHOD: THE SUBJECT DEVICES, 3 UNITS OF RD900AEU NEOPUFF INFANT RESUSCITATOR WERE RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CALIFORNIA WHERE THESE WERE 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 CENTER ALSO REPORTED THAT THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMER. RESULT: THE GAS OUTLET PORT OF THE SUBJECT DEVICES WAS FOUND TO BE DAMAGED DURING AN INSPECTION BY THE F&P SERVICE TECHNICIAN, CONFIRMING THE REPORTED COMPLAINT. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. 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. EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION.
A HEALTHCARE FACILITY IN MARYLAND HAS REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR'S GAS OUTLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN MARYLAND HAS REPORTED THAT THREE OF THEIR RD900AEU NEOPUFF INFANT RESUSCITATORS GAS OUTLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374716 | FISHER & PAYKEL HEALTHCARE | NEOPUFF INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AEU | 100619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |