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

Model Number 900MR810

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint 900mr810 adult heated wall reusable breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the customer reported that the tubing of the 900mr810 adult heated wall reusable breathing circuit was damaged.Conclusion: we are unable to determine the cause of the reported malfunction.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure 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 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 cover the circuit with materials such as blankets, towels or bed linen.''.

Event Description

A healthcare facility in (b)(6), reported that a 900mr810 adult heated wall reusable breathing circuit was damaged during use.There was no reported patient consequence.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618-2216 ; 9494534002
• MDR Report Key: 14431879
• MDR Text Key: 292021265
• Report Number: 9611451-2022-00472
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2101889008(11)211109
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

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: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: 2101889008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Treatment: HUMIDIFIER MR810