MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RT330 OPTIFLOW TUBING KIT; HEATED BREATHING CIRCUIT

Model Number	RT330
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Correction: section d4: model # and catalog # corrected to rt330.Section h11: method: the subject rt330 optiflow tubing kit, photographs, and additional information were requested to be provided to fisher & paykel healthcare for analysis.Neither the subject device, photographs, nor the additional information requested were provided for evaluation.Our evaluation is therefore based on the information provided by the healthcare facility, and our knowledge of the product.Results: without the return of the complaint device, photographs, or additional information, we are unable to determine the cause of the reported event.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm the reported issue or determine the cause of the reported event.Our user instructions that accompany the rt330 optiflow tubing kit show in pictorial format the correct set-up of the circuit and states the following: do not stretch or milk the tubing.Do not soak, wash, or sterilise this product.Avoid contact with chemicals, cleaning agents, or hand sanitisers.Visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- for use under the supervision of trained medical personnel.
Event or Problem Description
A healthcare facility in china reported that a rt330 optiflow tubing kit was found broken prior to patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt330 optiflow tubing kit, photographs, and additional information were requested to be provided to fisher & paykel healthcare for analysis.Neither the subject device, photographs, nor the additional information requested were provided for evaluation.Our evaluation is therefore based on the information provided by the healthcare facility, and our knowledge of the product.Results: without the return of the complaint device, photographs, or additional information, we are unable to determine the cause of the reported event.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm the reported issue or determine the cause of the reported event.Our user instructions that accompany the rt330 optiflow tubing kit show in pictorial format the correct set-up of the circuit and states the following: - do not stretch or milk the tubing.- do not soak, wash, or sterilise this product.Avoid contact with chemicals, cleaning agents, or hand sanitisers.- visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- for use under the supervision of trained medical personnel.
Event or Problem Description
A healthcare facility in china reported that a rt330 optiflow tubing kit was found broken prior to patient use.There was no reported patient consequence.

• Brand Name: RT330 OPTIFLOW TUBING KIT
• Common Device Name: HEATED BREATHING CIRCUIT
• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine 92618 ; 9494341005
• MDR Report Key: 19779989
• Report Number: 9611451-2024-00512
• Device Sequence Number: 8428987
• Product Code: BZE
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2101998264(11)220125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2101998264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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
• Patient Age: 2 DA
• Patient Sex: Female