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

Model Number	RT329
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare is currently in the process of finalizing the investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported that an mr290v vented autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit single heated with pressure relief valve was found leaking water during patient use.There was no reported patient harm.
Event or Problem Description
A healthcare facility in china reported that an mr290v vented autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit single heated with pressure relief valve was found leaking water during patient use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is therefore based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported that the mr290v humidification chamber base was leaking water.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported event.Every mr290v 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 rt329 breathing circuit state the following: "use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• 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 ; 9494341005
• MDR Report Key: 20288354
• Report Number: 9611451-2024-00680
• Device Sequence Number: 15256188
• Product Code: BTT
• UDI-Device Identifier: 09420012431073
• UDI-Public: (01)09420012431073(10)2103016326(11)240229
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: RT329
• Device Catalogue Number: RT329
• Device Lot Number: 2103016326
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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 Sex: Female