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 Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor in new york, reported that a 900mr810 adult heated wall reusable breathing circuit was damaged during use.There was no reported patient consequence.

Manufacturer Narrative

Ps402045 method: the complaint 900mr810 adult heated wall reusable breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for inspection where it was visually inspected.Results: visual inspection revealed that the tubing of the 900mr810 adult heated wall reusable breathing circuit damaged.Conclusion: we are unable to determine the cause of the reported malfunction, however it is most likely due to the tubing being poked and pierced through.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." - "do not cover the circuit with materials such as blankets, towels or bed linen." - "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".

Event Description

A distributor in new york, 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: 15255964
• MDR Text Key: 298297943
• Report Number: 9611451-2022-00773
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2102033904(11)220214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: 2102033904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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