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

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that five 900mr810 adult heated wall reusable breathing circuits were damaged during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) adult heated wall reusable breathing circuit was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected.Results: visual inspection revealed that there was helix delamination near the chamber end cuff.There were no signs of tearing or stretching on the tubing.Conclusion: we are unable to determine the cause of 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 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 taiwan reported via a fisher & paykel healthcare (f&p) field representative that five 900mr810 adult heated wall reusable breathing circuits were damaged during use.There was no 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 ; 9494534000
• MDR Report Key: 14183959
• MDR Text Key: 294606754
• Report Number: 9611451-2022-00363
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2101384973(11)201112
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

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: 2101384973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1