FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00098
- Event Type
- Malfunction
- Date Received
- February 15, 2024
- Report Date
- January 17, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- UDI-DI
- 09420012410931
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2: COMMON DEVICE NAME UPDATED TO INFANT RESUSCITATOR; PRODUCT CODE UPDATED TO FMT. SECTION D4: MODEL # AND CATALOG # UPDATED TO RD900AEU. SECTION G1: CONTACT DETAILS UPDATED TO (B)(6). SECTION G4: PMA/510(K) UPDATED TO K971965 TO ALIGN WITH GUDID. METHOD: THE RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN THE UNITED STATES, WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. THE UNIT WAS PERFORMANCE TESTED AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR CONFIRMED THAT THE GAS OUTLET PORT WAS DAMAGED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED FAULT. HOWEVER, IT IS LIKELY DUE TO PHYSICAL IMPACT. 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.
(B)(4) FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED THAT THE GAS OUTLET OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED THAT THE GAS OUTLET OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1519427 | FISHER & PAYKEL HEALTHCARE | INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AEU | 2101856279 | 09420012410931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |