MAUDE Adverse Event Report: REUSABLE HUMIDIFICATION CHAMBER; BTT

Model Number MR370

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in process of our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a distributor that a mr370 reusable humidification chamber had 'burst'.There was no patient involvement.

Event Description

A distributor in mongolia reported on behalf of a distributor that a mr370 reusable humidification chamber had 'burst'.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr370 reusable humidification chamber was not returned to our fisher & paykel healthcare (f&p) regional office for evaluation.Our investigation is based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photograph provided by the customer showed that the chamber dome was cracked.Conclusion: without the complaint device, we are unable to determine the cause of 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: "warning: to prevent cracking, ensure that the water inlet port plug, and any other reusable compounds, are disconnected from the chamber before cleaning." recommended way to clean the chamber: "chambers maybe cleaned by any of the following methods: autoclave: 132°c(270°f) @ 220kpa (32psi) for 4 minutes, or 121°c (250°f) @ 96kpa (14.1psi) for 30 minutes or ethylene oxide: 55°c (131°f)".

• Brand Name: REUSABLE HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 11918794
• MDR Text Key: 256721177
• Report Number: 9611451-2021-00619
• Device Sequence Number: 1
• Product Code: BTT
• 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: 04/28/2021

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: 200817466747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 07/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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