FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00531
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Report Date
- June 28, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012450029
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, 950N81J NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. FISHER AND PAYKEL HEALTHCARE (F&P) HAS REQUESTED THE RETURN OF THE SUBJECT (B)(6) NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO F&P NEW ZEALAND FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, 950N81J NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. CORRECTIONS: SECTION D1: BRAND NAME - CORRECTED TO "FISHER & PAYKEL HEALTHCARE" TO REFLECT GUDID. SECTION D2B: PRODUCT CODE - CORRECTED TO "BTT" TO REFLECT GUDID. SECTION D4: UDI - ADDED THE EXPIRY DETAILS TO UDI. METHOD: THE COMPLAINT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS REQUESTED, HOWEVER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION, PHOTOGRAPH OF THE CIRCUIT PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH REVEALED THAT THE COVER MIDPOINT NEO 950 OF THE NEONATAL INSPIRATORY LIMB WAS OBSERVED TO HAVE A VISIBLE GAP AT THE JOINT OF THE MIDPOINT COVER. IT IS NOT A CRACK THAT WOULD CAUSE A GAS LEAKAGE. THE COVER MIDPOINT NEO 950 IS A PURELY COSMETIC COVER AND DOES NOT IMPACT ON THE PERFORMANCE OR SAFETY OF THE INSPIRATORY LIMB IN ANY WAY. CONCLUSION: WITHOUT THE DEVICE BEING RETURNED FOR INVESTIGATION, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. ALL 950N81 CIRCUIT KIT ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950N81 NEONATAL VENTED DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: "DO NOT CRUSH, STRETCH OR MILK THE TUBING." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT." "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." THE USER INSTRUCTIONS ALSO WARN THE USER: SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH."
A HEALTHCARE FACILITY IN SPAIN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING DURING PATIENT USE. NO PATIENT CONSEQUENCES WERE REPORTED. HEALTHCARE FACILITY FURTHER REPORTED THAT THERE WAS NO VISIBLE DAMAGE ON THE CIRCUIT.
A HEALTHCARE FACILITY IN SPAIN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING DURING PATIENT USE. NO PATIENT CONSEQUENCES WERE REPORTED. HEALTHCARE FACILITY FURTHER REPORTED THAT THERE WAS NO VISIBLE DAMAGE ON THE CIRCUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357342 | FISHER & PAYKEL HEALTHCARE | BZE | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950N81 | 2102958913 | 09420012450029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |