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

Model Number	MR370
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
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 distributor reported on behalf of a healthcare facility in china that an mr370 reusable humidification chamber dome was found cracked during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr370 reusable humidification chamber was not received for analysis.Our investigation is therefore based on the photograph and information provided by the healthcare facility and our knowledge of the product.Results: review of the photograph provided by the healthcare facility confirmed a crack at the dome of the chamber.Conclusion: without the device being returned to f&p healthcare nz for further investigation it is not possible to determine the cause of the crack.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." - "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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that an mr370 reusable humidification chamber dome was found cracked during patient use.There was no reported patient consequence.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA ; 9494341005
• MDR Report Key: 20502091
• Report Number: 9611451-2024-00765
• Device Sequence Number: 8402287
• Product Code: BTT
• UDI-Device Identifier: 09420012401618
• UDI-Public: (01)09420012401618(10)2103187099(11)240614
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: MR370
• Device Catalogue Number: MR370
• Device Lot Number: 2103187099
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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