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

Model Number	MR340E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
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 distributor in china reported that a mr340e reusable humidification chamber was found leaking water before patient use.There was no patient involvement.
Event or Problem Description
A distributor in china reported that a mr340e reusable humidification chamber was found leaking water before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The mr340 is a reusable chamber for heating and humidifying respiratory gases for pediatric and neonatal patients requiring respiratory support.It is intended for use with fisher & paykel healthcare mr850 humidifiers in hospital or clinical environments and should only be prescribed by a physician.Addition of heat and humidity to the supply of cold and dry respiratory gases provided through ventilation is beneficial to prevent drying of the patient's airways.Method: the mr340e reusable humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected and analyzed.Results: visual inspection of returned device revealed no damage was observed on the chamber, o-ring and base.Further inspection revealed an uneven chamfered base flange was observed and the circumference of base flange warped into an oval shape.Water leaking was confirmed when the returned chamber was connected to the water source.The base flange outer and inner diameter measurements that were taken at cross section of leaking site was found to be out specification.Conclusion: the chamber dome leaking is most likely due to chamber being warped into an oval shape and base flange outer and inner diameter being out of specification during moulding process.The side that has largest diameter has caused the o-ring to not seal properly and thus creating a gap between the wall of chamber and created a leak.Based on the provided lot details, the complaint device was manufactured by our old supplier.We have since changed to a different supplier.All mr340e chambers are visually inspected before leaving the production line and those that fail are rejected.Our user instructions that accompany the mr340e reusable humidification chamber 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, damage.These may cause gas leaks and loss of ventilation or respiratory support.".

• Brand Name: REUSABLE HUMIDIFICATION CHAMBER
• Common Device Name: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16127918
• Report Number: 9611451-2023-00002
• Device Sequence Number: 7636150
• Product Code: BTT
• UDI-Device Identifier: 09420012401588
• UDI-Public: (01)09420012401588(10)2101366823(11)201102
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K934140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 2101366823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: Unknown