MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number	RT280
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt280 adult dual-heated evaqua2 breathing circuit is 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 healthcare facility in new york reported via a fisher & paykel healthcare (f&p) field representative, that two rt280 adult dual-heated evaqua2 breathing circuits were found damaged before patient use.There was no patient involvement.
Event or Problem Description
A healthcare facility in new york reported via a fisher & paykel healthcare (f&p) field representative, that two rt280 adult dual-heated evaqua2 breathing circuits were found damaged before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: one of the complaint rt280 adult dual-heated evaqua2 breathing circuits was returned to fisher & paykel healthcare in new zealand, where it was visually inspected.Results: visual inspection revealed a cut on the tubing of inspiratory limb.The cut appeared to have been made by a sharp object.Conclusion: we are unable to determine the root cause of the reported event, however the damage appeared to be the result of the circuit bag having been opened with a knife or box cutter.All breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuits would have met the required specifications at the time of production.The user instructions that accompany the rt280 adult dual-heated evaqua2 breathing circuit states the following: "visually inspect breathing sets for damage before use and replace if damaged." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient." "check all connections are tight before use.".

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Common Device Name: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16595143
• Report Number: 9611451-2023-00248
• Device Sequence Number: 11171419
• Product Code: BZE
• UDI-Device Identifier: 09420012430373
• UDI-Public: (01)09420012430373(10)2102379518(11)221015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: RT280
• Device Catalogue Number: RT280
• Device Lot Number: 2102379518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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