MAUDE Adverse Event Report: REUSABLE HUMIDIFICATION CHAMBER; BTT

Model Number MR370

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr370 was recently received at fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor in (b)(4) reported that the mr370 reusable humidification chamber was leaking water from the chamber base.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) reusable humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and further analysed.Results: visual inspection of the returned chamber observed that there was an insufficient seal between the o-ring seal and chamber base.Functional testing of the chamber confirmed that it was leaking from the base.Measurement of the o-ring confirmed that it was outside of specifications.Conclusion: based on our investigation, the cause of the reported water leak was due to the o-ring being outside of specifications.The supplier of the o-ring has been notified of this issue and is conducting their own investigation.Our user instructions that accompany the mr370 reusable humidification chamber state the following: - "maximum operating pressure: 20 kpa".- "warning: 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 Description

A distributor in china reported that the mr370 reusable humidification chamber was leaking water from the chamber base.There was no patient involvement.

• Brand Name: REUSABLE HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 11092497
• MDR Text Key: 240031779
• Report Number: 9611451-2020-01236
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012401618
• UDI-Public: 010942001240161810
• Combination Product (y/n): N
• PMA/PMN Number: K913368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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
• Patient Outcome(s): Required Intervention