MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT HEATED WALL REUSABLE BREATHING CIRCUIT; BTT

Model Number 900MR810

Device Problems Melted (1385); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900mr810 adult heated wall reusable breathing circuit is currently en route to f&p in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported on (b)(6) 2019 that a fisher & paykel healthcare (f&p) mr810 respiratory humidifier was being used while the patient's breathing circuit had melted and burnt the patient's pillow.No further information was provided about the brand of breathing circuit at initial reporting.After contacting the complainant for further information, it was reported on (b)(6) 2019 that the breathing circuit that melted was an f&p 900mr810 adult heated wall reusable breathing circuit.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: after submission of the initial report, the customer indicated that the complaint 900mr810 adult heated wall reusable breathing circuit was discarded following the event and was not available to be returned to fisher & paykel healtchare (f&p) in new zealand for evaluation.Our investigation is thus based upon the event description and photographs provided by the customer, as well as our knowledge of the product.The customer indicated that the device was resting on the patient's pillow , but did not answer whether the 900mr810 tubing was covered at the time of the reported incident.It was also reported that the 900mr810 circuit was used for an average of six hours per day, and that the respiratory therapist had frequently observed the breathing circuit resting on the patient's pillow.Results: visual inspection of the photographs provided showed burn marks on a pillow, and the configuration of a breathing circuit with respect to the burn marks.The circuit shown in the configuration photograph did not show any signs of damage, deformation, or melting.No information was provided as to whether the circuit shown in the photograph was the complaint breathing circuit or a sample used for illustrative purposes.Conclusion: without the complaint 900mr810 adult heated wall reusable breathing circuit or a photograph showing the reported damages, we are unable to determine what may have caused the reported event.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure tested prior to being released for distribution.Any circuits that fail these tests are rejected.This complaint 900mr810 adult heated wall reusable breathing circuit met the required specifications at the time of production.The user instructions that accompany the 900mr810 adult heated wall reusable breathing circuit state the following: "inspect circuit before re-use, do not use if the circuit shows signs of deterioration, such as: cracks, tears, or damage." "perform a pressure and leak test on the breathing system, and check for occlusions, before connecting to a patient." "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage." "do not use the heated breathing circuit without gas flow.If gas flow is interrupted turn the humidifier off." "do not cover the circuit with materials such as blankets, towels or bed linen.".

Event Description

A healthcare facility in florida reported on (b)(6) 2019 that a fisher & paykel healthcare (f&p) mr810 respiratory humidifier was being used while the patient's breathing circuit had melted and burnt the patient's pillow.No further information was provided about the brand of breathing circuit at initial reporting.After contacting the complainant for further information, it was reported on (b)(6) 2019 that the breathing circuit that melted was an f&p 900mr810 adult heated wall reusable breathing circuit.There was no patient consequence.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8639217
• MDR Text Key: 146248657
• Report Number: 9611451-2019-00521
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P MR810 RESPIRATORY HUMIDIFIER; F&P MR810 RESPIRATORY HUMIDIFIER; RESMED F20 AIRTOUCH FACEMASK; RESMED F20 AIRTOUCH FACEMASK