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

Model Number	RT225
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare is currently in the process of finalizing the investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported that an rt225 infant ventilator circuit single heated with mr290 autofeed chamber was found damaged during patient use.There were no patient consequences reported.
Event or Problem Description
A healthcare facility in china reported that an rt225 infant ventilator circuit single heated with mr290 autofeed chamber disconnected during patient use.There were no patient consequences reported.
Additional Manufacturer Narrative
Ps455195.Method: the subject rt225 breathing circuit was not returned to fisher & paykel (f&p) healthcare new zealand for evaluation.Our investigation is therefore based on the information, photographs and video provided by the healthcare facility, and our knowledge of the product.Results: the information, photographs and video provided by the healthcare facility shows that when flow from the blender was applied to the rt225 breathing circuit, the dryline disconnected from the humidification chamber port.Further photographs provided show the complete setup with the rt225 breathing circuit and non-f&p healthcare devices, including a bubble cpap device.Conclusion: the photographs and video provided by the healthcare facility show the rt225 breathing circuit being used with bubble cpap and also using syringes to connect the breathing tubes to the nasal cannula.The rt225 breathing circuit is intended for use with a ventilator.Using such a setup is likely to have created a significant pressure buildup within the system, causing the rt225 breathing circuit dryline to disconnect from the humidification chamber port.All rt225 infant bias flow breathing 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 breathing circuit state the following: the use of breathing circuits, chambers, accessories, or combination which are not approved by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction and harm to the patient/user.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 connection to a patient.Check all connections are tight before use.

• 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: 20104385
• Report Number: 9611451-2024-00634
• Device Sequence Number: 18110230
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2102632318(11)230529(17)280529
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: 2102632318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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: COMEN KL-20 LOW FLOW AIR-OXYGEN BLENDER; FISHER & PAYKEL HEALTHCARE MR810 RESPIRATORY HUMID; OXYGEN NASAL CANNULA TUBE OF UNSPECIFIED BRAND; SYRINGES OF UNSPECIFIED BRAND; UNSPECIFIED NON-F&P HEALTHCARE BUBBLE CPAP
• Patient Sex: Unknown