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

Model Number	RT280
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt280 adult dual heated evaqua2 breathing circuit has been requested to be returned to f&p healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility reported via a fisher & paykel (f&p) healthcare representative, that a rt280 adult evaqua2 dual heated breathing circuit was found damaged during patient use.The damage was identified after approximately 10 minutes of patient use when the ventilator alarmed for low volume.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4), corrected data: section e1 - initial reporter address - update of the street.Section g2 - report source - correction of data.Section h11: method: the expiratory tubing of the subject rt280 adult dual-heated evaqua2 breathing circuit was received at f&p healthcare in new zealand for evaluation, where it was visually inspected and analysed.Results: visual inspection of the expiratory tube confirmed that the evaqua2 limb was damaged.Further analysis performed on the tube confirmed that the damage was due to chemical exposure.Conclusion: based on the investigation, the observed damage was likely due to chemical exposure, however we are unable to identify the source of the chemical.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.".
Event or Problem Description
A healthcare facility reported via a fisher & paykel (f&p) healthcare representative, that a rt280 adult evaqua2 dual heated breathing circuit was found damaged during patient use.The damage was identified after approximately 10 minutes of patient use.There were no patient consequences reported.

• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18620111
• Report Number: 9611451-2024-00058
• Device Sequence Number: 7444564
• Product Code: BZE
• UDI-Device Identifier: 09420012430373
• UDI-Public: (01)09420012430373(10)2102683175(11)230715
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 2102683175
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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