MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FISHER & PAYKEL HEALTHCARE; REUSABLE HUMIDIFICATION CHAMBER

Model Number	MR340E
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject r340e humidification chamber has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in indonesia reported on behalf of a healthcare facility that an mr340e reusable humidification chamber failed the ventilator pre-use leak test.There was no patient involvement.
Event or Problem Description
A distributor in indonesia reported on behalf of a healthcare facility that an mr340e reusable humidification chamber failed the ventilator pre-use leak test.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr340e humidification chamber was not returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Our investigation is therefore based on the limited information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported that the humidification chamber was leaking air.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported event.Every mr340e 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 mr340e humidification chamber would have met the required specifications at the time of production.The user instructions that accompany the mr340e reusable humidification chambers state the following: - ensure the mr340 o-ring is not twisted when inserted into the chamber base groove and that the chamber dome is pushed fully onto the chamber base as per the chamber assembly instructions.- visually inspect products before each use on a patient.Discard if faulty or if there is any sign of deterioration such as cracks, tears or damage.These may cause gas leaks and loss of ventilation or respiratory support.- before connecting to a patient, ensure the complete circuit functions correctly with required ventilator settings and appropriate ventilator or flow source alarms are set.- check all connections are tightly secured before use.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: REUSABLE HUMIDIFICATION CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 22208718
• Report Number: 9611451-2025-00554
• Device Sequence Number: 12916568
• Product Code: BTT
• UDI-Device Identifier: 09420012401588
• UDI-Public: (01)09420012401588(10)2103155891(11)240527
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K913368
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: MR340E
• Device Catalogue Number: MR340E
• Device Lot Number: 2103155891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 06/15/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown