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

Model Number	RT225
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject rt225 infant ventilator circuit was not returned to fisher & paykel (f&p) healthcare new zealand for evaluation as the device had been discarded by the healthcare facility.Our investigation is therefore based on the information provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that an rt225 infant ventilator circuit failed the ventilator leak test prior to patient use.The subject device was not returned to f&p healthcare in new zealand for evaluation.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to confirm or determine the cause of the reported issue.All rt225 infant ventilator circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt225 infant ventilator circuit show in pictorial format the correct set-up of the circuit and also states the following: - check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.
Event or Problem Description
A healthcare facility in china reported that an rt225 infant ventilator circuit failed a ventilator leak test prior to patient use.There was no patient involvement.

• 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: 20298091
• Report Number: 9611451-2024-00689
• Device Sequence Number: 7588738
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2102948195(11)240116(17)290116
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2102948195
• 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: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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
• Patient Sex: Unknown