MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	900MR810
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in taiwan reported, via a fisher & paykel healthcare (f&p) field representative, that a 900mr810 adult heated wall reusable breathing circuit was damaged.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).The complaint (b)(4) 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.
Additional Manufacturer Narrative
(b)(4).Method: the complaint 900mr810 adult heated wall reusable breathing circuit was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint 900mr810 adult heated wall reusable breathing circuit confirmed there wasa small hole in the tube 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.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 healthcare facility in taiwan reported, via a fisher & paykel healthcare (f&p) field representative, that a 900mr810 adult heated wall reusable breathing circuit was damaged.There was no reported patient consequence.
Event or Problem Description
A healthcare facility in taiwan reported, via a fisher & paykel healthcare (f&p) field representative, that a 900mr810 adult heated wall reusable breathing circuit was damaged.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).**udi related data quality updates only** corrections to reflect gudid: section d1: brand name updated to fisher & paykel healthcare section d2a: common device name updated to breathing circuit section d4: lot number and udi details were not provided by the healthcare facility section g1: contact person updated to mr.(b)(6).Section h5: labeled for single use updated to no method: the complaint 900mr810 adult heated wall reusable breathing circuit was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint 900mr810 adult heated wall reusable breathing circuit confirmed there wasa small hole in the tube 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.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".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18371584
• Report Number: 9611451-2023-01220
• Device Sequence Number: 12690454
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2102629375(11)230525
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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: NOT PROVIDED
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 01/12/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/08/2024; 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown