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

Model Number 900MR810

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher and paykel (f&p) are currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in france reported that a 900mr810 adult heated wall reusable breathing circuit had melted after use.There were no reported patient consequences.

Event Description

A healthcare facility in france reported that a 900mr810 adult heated wall reusable breathing circuit had melted after patient use.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the subject 900mr810 adult heated wall reusable breathing circuit was not returned to f&p for evaluation.Our investigation is based on the photographs and description of events provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the breathing circuit film was melted and had a stretched helix.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported malfunction.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damage occurred after the subject breathing circuit was released for distribution.The user instructions that accompany the 900mr810 adult heated wall reusable breathing circuits 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." -"do not cover the circuit with materials such as blankets, towels or bed linen." -"disconnect tube by handling end connectrs only, do not pull or twist tubing, as this may cause damage.".

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18367584
• MDR Text Key: 331051117
• Report Number: 9611451-2023-01196
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131957
• 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,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P MR810 HUMIDIFIER; F&P MR810 HUMIDIFIER; LUISA VENTILATOR; LUISA VENTILATOR