MalfunctionCAT
FISHER AND PAYKEL HEALTHCARE
Received Mar 31, 2026
Report 9611451-2026-01064 · MDR key 24750337
Device
Generic name
Nasal Cannula
Manufacturer
Fisher & Paykel Healthcare LtdModel number
OPT314Catalog number
OPT314
Lot number
2103606940
Product problems
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT CONSEQUENCE.