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

Model Number	MR370
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 healthcare facility in china reported that a mr370 reusable humidification chamber was found cracked before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint mr370 reusable humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer and our knowledge of the product.Results: review of the provided photographs revealed that a crack line was propagating upward from bottom of dome.It was declared by the customer that they failed to separate the chamber from the base during cleaning.It was also observed to have crack line localized at the inlet port.The customer further noted that the fault was only encountered to a particular hospital branch where a non-f&p connectors were used which were believed to have larger size.Conclusion: based on the investigation conducted, the reported fault was most likely caused by not separating the chamber dome from the base during cleaning, and the use of non-f&p connectors that were larger in size.All mr370 chambers are visually inspected before leaving the production line and those that fail are rejected.The subject mr370 chamber would have met the required specification at the time of production.Our 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.".
Event or Problem Description
A healthcare facility in china reported that a mr370 reusable humidification chamber was found cracked before patient use.There was no patient involvement.

• 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: 15840932
• Report Number: 9611451-2022-01072
• Device Sequence Number: 12488100
• Product Code: BTT
• UDI-Device Identifier: 09420012401618
• UDI-Public: (01)09420012401618(10)2101839625(11)211009
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 2101839625
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-F&P CONNECTORS.
• Patient Sex: Unknown