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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 NASAL CANNULA; CAT
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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 NASAL CANNULA; CAT Back to Search Results
Model Number OJR412
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A healthcare facility in australia reported, via a fisher and paykel healthcare (f&p) field representative, that an ojr412 optiflow junior nasal cannula broke during use.There were no reported patient consequences.
 
Manufacturer Narrative
(b)(4).We have requested the return of the complaint ojr412 optiflow junior nasal cannula for investigation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint ojr412 optiflow junior 2 nasal was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint cannula revealed that one tube was detached from the cannula joint.Glue residue was observed at the detached tube end.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by the tubing being pulled.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: 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.Do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).Ensure all connections are secure during use.Check the cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.
 
Event Description
A healthcare facility in australia reported, via a fisher and paykel healthcare (f&p) field representative, that an ojr412 optiflow junior nasal cannula broke during use.There were no reported patient consequences.
 
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Brand Name
OPTIFLOW JUNIOR 2 NASAL CANNULA
Type of Device
CAT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
omid taheri
17400 laguna canyon road
suite 300
irvine, CA 92618
8007923912
MDR Report Key18349105
MDR Text Key331065316
Report Number9611451-2023-01163
Device Sequence Number1
Product Code CAT
UDI-Device Identifier09420012435910
UDI-Public(01)09420012435910(10)2102512579(11)230210
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOJR412
Device Catalogue NumberOJR412
Device Lot Number2102512579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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