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

Model Number	RT385
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject rt385 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation as the device had been discarded by the healthcare facility.Our evaluation is therefore based on the information and photographs provided by the healthcare facility, and our knowledge of the product.Results: the customer reported that the expiratory tube of an rt385 adult dual heated evaqua2 breathing circuit was damaged.It was further reported that the device was in use for 6 days and drugs were nebulized into the system.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported damage.However, based on the information provided, the cause is most likely due to the chemicals introduced to the system.All rt385 adult dual heated evaqua2 breathing circuits are visually inspected, as well as pressure and flow tested during production, and those that fail the test are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.Check all connections are tight before use.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Ensure appropriate ventilator and 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 connecting to a patient.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the expiratory tube of an rt385 adult dual heated evaqua2 breathing circuit was found damaged during patient use.There was no patient harm reported.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the expiratory tube of an rt385 adult dual heated evaqua2 breathing circuit was found damaged during patient use.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Corrections: section d4: expiration date corrected.Method: the subject rt385 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation as the device had been discarded by the healthcare facility.Our evaluation is therefore based on the information and photographs provided by the healthcare facility, and our knowledge of the product.Results: the customer reported that the expiratory tube of an rt385 adult dual heated evaqua2 breathing circuit was damaged.It was further reported that the device was in use for 6 days and drugs were nebulized into the system.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported damage.However, based on the information provided, the cause is most likely due to the chemicals introduced to the system.All rt385 adult dual heated evaqua2 breathing circuits are visually inspected, as well as pressure and flow tested during production, and those that fail the test are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- check all connections are tight before use.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- ensure appropriate ventilator and 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 connecting to a patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20754042
• Report Number: 9611451-2024-00862
• Device Sequence Number: 18240866
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2103050529(11)240322(17)290322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2024

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: RT385
• Device Catalogue Number: RT385
• Device Lot Number: 2103050529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BUDESONIDE DRUG; BUDESONIDE DRUG; FLUTICASONE DRUG; FLUTICASONE DRUG
• Patient Sex: Unknown