FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00535
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- June 7, 2024
- Report Date
- July 3, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
(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.
(B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2: COMMON DEVICE NAME UPDATED TO INFANT RESUSCITATOR, AND PRODUCT CODE UPDATED TO FMT. SECTION D4: MODEL# AND CATALOG# UPDATED TO RD900AEU. SECTION D4: UDI IS UNAVAILABLE. SECTION G4: 510(K) NUMBER UPDATED TO K971965. 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. RESULTS: THE PERFORMANCE TEST OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE GAS OUTLET PORT AND TUBES HAD NO FLOW DUE TO INTERNAL DAMAGE AND CRACKS. UPON FURTHER INSPECTION, IT WAS CONFIRMED THAT THE INTERNAL GAS SUPPLY LINES WERE CRACKED, RESULTING IN A LOOSE GAS INLET, NO FLOW TO THE GAS OUTLET, AND NO MOVEMENT OF THE MANOMETER. THE MANOMETER WAS FURTHER PERFORMANCE TESTED, AND WAS CONFIRMED TO BE FUNCTIONING AS INTENDED WITH SMOOTH AND ACCURATE READINGS. CONCLUSION: THERE WAS NO FLOW DUE TO THE INTERNAL GAS SUPPLY LINES BEING CRACKED. 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.
A HEALTHCARE FACILITY REPORTED THAT THE GAS INLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS LOOSE, AND THAT THE GAUGE HAD NO MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
A HEALTHCARE FACILITY REPORTED THAT THE GAS INLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS LOOSE, AND THAT THE GAUGE HAD NO MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2366915 | FISHER & PAYKEL HEALTHCARE | INFANT RESUSCITATOR | FMT | FISHER & PAYKEL HEALTHCARE LTD | RD900AEU | 130117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |