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

Model Number MR290V

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 auto-feed humidification chambers were discarded by the customer after the reported event, and are thus not available to be returned to fisher & paykel healthcare in (b)(4) for evaluation.We are in the process of gathering additional information from the customer regarding the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that three mr290v vented auto-feed humidification chambers had melted.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The complaint mr290 autofeed humidification chambers were discarded by the customer after the reported event, and were thus not available to be returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Upon receipt of this complaint, additional information about the incident was sought from the customer in order to establish the chain of events leading up to the incident.We also were keen to establish what other devices were in use with the mr290 chambers and whether the chambers had been allowed to run dry.The customer reported that "they made sure to not let the water run out and to shut off when not in use." it was also reported that the f&p mr850 respiratory humidifier was checked by the "biomed department" at the user facility and was found to be operating within specifications.The customer did not respond to our questions related to the presence of an external heat source.Without the complaint devices and any additional information, we are not able to identify the cause of the reported melted mr290 chambers.It is possible for the mr290 chamber to deform due to excessive heat caused by loss of humidity, but this can only occur if the chamber runs dry and is left to continue operation for a prolonged period of time with no humidity.When the chamber runs out of water, the f&p mr850 humidifier displays a visual and audible alarm to alert the caregiver so that the water bag can be replaced.All chambers are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The complaint mr290 chambers would have met the required specifications at the time of production.The user instructions which accompany the mr290 chamber state the following: ensure there is a water supply connected to the chamber and that water is present within the chamber.Set appropriate ventilator alarms.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.

Event Description

A healthcare facility in minnesota reported that three mr290v vented autofeed humidification chambers had melted.There was no reported patient consequence.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8657034
• MDR Text Key: 146658394
• Report Number: 9611451-2019-00546
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER