MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER AND PAYKEL HEALTHCARE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	OJR412VT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) has requested subject device return from the healthcare facility and is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in illinois has reported via a fisher & paykel healthcare (f&p) field representative that the ojr412vt optiflow junior 2 ventilator transition kit s's tubing was detached from the cannula tube joint during patient use.A healthcare facility further reported that there are two cannulas effected due to the reported failure.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: both the complaint devices ojr412vt optiflow junior 2 ventilator transition kit ss were received at fisher & paykel healthcare (f&p) new zealand, where they were visually inspected.Our investigation is based on the information provided by the customer, evaluation of the returned devices and our knowledge of the product.Results: visual inspection of the returned cannulas revealed that the tubing was detached from the left side of the cannula tube joint with the visible glue residue on surface of the detached tube and inside the cannula tube joint.Conclusion: we are unable to determine the cause of the reported fault.The optiflow junior cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and pediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula tube joint, as well as the swivel grip joint, if there are any failures the entire batch is put aside for further investigation.The subject ojr412vt optiflow junior 2 ventilator transition kit s would have met the required specifications at the time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 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 or Problem Description
A healthcare facility in (b)(6) has reported via a fisher & paykel healthcare (f&p) field representative that the ojr412vt optiflow junior 2 ventilator transition kit s's tubing was detached from the cannula tube joint during patient use.A healthcare facility further reported that there are two cannulas effected due to the reported failure.There was no reported patient consequence.

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20413859
• Report Number: 9611451-2024-00724
• Device Sequence Number: 8380947
• Product Code: BTT
• UDI-Device Identifier: 09420012448958
• UDI-Public: (01)09420012448958(10)2102851202(11)231026(17)261026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K222197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OJR412VT
• Device Catalogue Number: OJR412VT
• Device Lot Number: 2102851202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OJT412VT LOT#2102851202.; OJT412VT LOT#2102851202.
• Patient Sex: Unknown