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

Model Number	900MR810
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9611451-2022-00773
• Device Sequence Number: 12428207
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2102033904(11)220214
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown