FDA Adverse Event
Malfunction
Summary report: N
FISHER & PAYKEL HEALTHCARE
MDR report key: 24892000
·
Received April 15, 2026
Report
- Report Number
- 9611451-2026-01279
- Event Type
- Malfunction
- Date Received
- April 15, 2026
- Date of Event
- March 9, 2026
- Report Date
- April 16, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- UDI-DI
- 09420012450029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(6). SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SINGAPORE, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE EXPIRATORY LIMB OF AN 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS FOUND BROKEN AND LEAKING WATER DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577597 | FISHER & PAYKEL HEALTHCARE | BREAHTING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | 950N81 | 2102575494 | 09420012450029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |