MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	RT330
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently 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 taiwan reported that an mr290v vented autofeed humidification chamber, provided as part of an rt330 adult optiflow tubing kit, was found leaking water during patient use.There was no patient harm reported.
Event or Problem Description
A healthcare facility in taiwan reported that an mr290v vented autofeed humidification chamber, provided as part of an rt330 adult optiflow tubing kit, was found leaking water during patient use.There was no patient harm reported.
Additional Manufacturer Narrative
Ps454546.Corrections: section d2a: corrected common device name.Section d4: model and catalog # corrected to rt330.Section g4: updated 510(k).Section e1: corrected.Section h11: method: the subject mr290v vented autofeed humidification chamber and additional information were requested to be provided to fisher & paykel (f&p) healthcare in new zealand for evaluation.Neither the subject device nor the information was provided.Our evaluation is therefore based on the limited information provided by the healthcare facility, and our knowledge of the product.Results: the customer reported that an mr290v vented autofeed humidification chamber, provided as part of an rt330 adult optiflow tubing kit, was found leaking water from the base of the chamber during patient use.Neither the subject device nor the requested additional information were returned to f&p healthcare for evaluation.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm or determine the cause of the reported event.Every mr290v humidification chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v humidification chamber would have met the required specifications at the time of production.The user instructions that accompany the rt330 optiflow tubing kit state the following: do not use the chamber if the seals are not intact when received, or if it has been dropped.Ensure there is a water supply connected to the chamber and that water is present within the chamber.Appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.Visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: 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, CA 92618 ; 8007923912
• MDR Report Key: 20005042
• Report Number: 9611451-2024-00596
• Device Sequence Number: 17381875
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2102903352(11)231129(17)281129
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2102903352
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RT330 ADULT OPTIFLOW TUBING KIT
• Patient Sex: Unknown