F&P Optiflow Junior 2 OJR414VTRecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior 2 Ventilator Transition Kit · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012448972), received between Sep 25, 2024 and Mar 31, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR414VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THE DEVICE WAS REPLACED AND NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750335 ↗MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN (B)(6) REPORTED THAT THE TUBING OF THE OJR414VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS FOUND DISCONNECTED AT THE NASAL INTERFACE ON BOTH SIDES. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21454644 ↗MalfunctionJan 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN SOUTH DAKOTA REPORTED THAT THE OJR414VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS FOUND DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21268342 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOM HAS REPORTED THAT THE TUBING OF AN OJR414VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT M WAS DETACHED FROM THE CANNULA TUBE JOINT DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298044 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.