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

Model Number MR370

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event 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.

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 provided by the customer and our knowledge of the product.Results: the customer reported that a mr370 reusable humidification chamber was found leaking water during patient use.Conclusion: without the complaint device, we are unable to draw any reasonable conclusions about the reported event.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.".

• Brand Name: REUSABLE HUMIDIFICATION CHAMBER
• Type of Device: 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: 16344601
• MDR Text Key: 309303685
• Report Number: 9611451-2023-00085
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2023

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
• Device Operator: Health Professional
• Device Model Number: MR370
• Device Catalogue Number: MR370
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1