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

Model Number	MR370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported that a mr370 reusable humidification chamber was found leaking water during patient use.There was no patient consequence.
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.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr370 reusable humidification chamber was not received for analysis.Our investigation is therefore based on the video and information provided by the healthcare facility and our knowledge of the product.Results: review of the video file provided by the healthcare facility confirmed a leak from the dome of the chamber.It is possible that the chamber dome may be cracked, however it is not possible to confirm this from the video alone.Conclusion: without the device being returned to f&p healthcare nz for further investigation it is not possible to determine the cause of the water leak.The user instructions that accompany the mr370 reusable humidification chamber state the following: "the following solutions should be avoided as they may cause the chamber to crack: ketones, formaldehyde, chlorinated hydrocarbons, hypochlorite, inorganic acids, aromatic hydrocarbons, phenol (>5%)" "to prevent cracking, ensure that the water inlet port plug, and any other reusable components, are disconnected from the chamber before cleaning." "ensure the mr370 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." "do not use breathing circuits, chambers, accessories or combinations which are not approved by fisher & paykel healthcare.".
Event or Problem Description
A healthcare facility in china reported that a mr370 reusable humidification chamber was found leaking water during patient use.There was no patient consequence.

• Brand Name: REUSABLE HUMIDIFICATION CHAMBER
• Common Device Name: REUSABLE HUMIDIFICATION CHAMBER
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 19048067
• Report Number: 9611451-2024-00275
• Device Sequence Number: 8548473
• Product Code: BTT
• UDI-Device Identifier: 09420012401618
• UDI-Public: (01)09420012401618(10)2101029291(11)200304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Expiration Date: 03/04/2025
• Device Model Number: MR370
• Device Catalogue Number: MR370
• Device Lot Number: 2101029291
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown