MAUDE Adverse Event Report: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT; BTT

Model Number	900MR810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs provided revealed 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, however it is most likley due to the tubing being punctured.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.".
Event or Problem Description
A healthcare facility in (b)(6) 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.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 11972058
• Report Number: 9611451-2021-00675
• Device Sequence Number: 4268878
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: (01)09420012432247(10)2101384973(11)201112
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 2101384973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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