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

Model Number	RT225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that a mr290v vented autofeed humidification chamber was found leaking water between the chamber's dome and base during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that a mr290v vented autofeed humidification chamber was found leaking water between the chamber's dome and base during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber was not returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Our investigation is therefore based on the information, photographs, and videos provided by the healthcare facility, and our knowledge of the product.Results: a review of the provided photographs and videos confirmed that the mr290v humidification chamber was leaking water between the chamber's dome and base.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to determine the cause of the leak.Every mr290v chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v humidification chamber would have met the required specifications at the time of production.The user instructions that accompany the mr290v humidification chamber state the following: do not use the chamber if the seals are not intact when received, or if it has been dropped.Visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.Ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Ensure there is a water supply connected to the chamber and that water is present within the chamber.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that an mr290v vented autofeed humidification chamber provided with an rt225 infant ventilator circuit was found leaking water between the chamber's dome and base during use.
Additional Manufacturer Narrative
(b)(4).Corrections: section d1: brand name updated to fisher & paykel healthcare section d2a: common device name updated to breathing circuit section d2b: product code updated to bze section d4: model and catalog # updated to rt225 section d4: lot number updated section d4: expiration date updated section d4: udi details added section g3: date corrected section g4: pma/510(k) number updated section h4: date of manufacture updated section h11: user instructions updated section h11: method: the subject mr290v vented autofeed humidification chamber was not returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Our investigation is therefore based on the information, photographs, and videos provided by the healthcare facility, and our knowledge of the product.Results: a review of the provided photographs and videos confirmed that the mr290v humidification chamber was leaking water between the chamber's dome and base.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to determine the cause of the leak.Every mr290v chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v humidification chamber would have met the required specifications at the time of production.The user instructions that accompany the rt225 infant ventilator circuit state the following: - do not use the chamber if the seals are not intact when received, or if it has been dropped.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.

• 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: 19525395
• Report Number: 9611451-2024-00420
• Device Sequence Number: 7704588
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2102530939(11)230227(17)280227
• 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,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 2102530939
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 06/26/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/23/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED; RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED; RT225 INFANT VENTILATOR CIRCUIT SINGLE HEATED
• Patient Sex: Unknown