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

Model Number	RT202
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt202 adult inspiratory heated breathing circuit has been requested to be returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in the united kingdom reported that a rt202 adult inspiratory heated breathing circuit was found leaking from the connection of inspiratory chamber port.There was no patient consequence reported.
Event or Problem Description
A healthcare facility in the united kingdom reported that a rt202 adult inspiratory heated breathing circuit was found leaking droplets of water from the connection of the inspiratory chamber port.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt202 adult inspiratory heated breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is thus based on the information and video provided by the customer and our knowledge of the product.Results: the customer reported that a rt202 adult inspiratory heated breathing circuit was found leaking from the connection of inspiratory chamber port.Conclusion: the subject rt202 adult inspiratory heated breathing circuit was requested to be returned for evaluation, however, it was not provided.Without the return of the subject device, we are unable to confirm a fault, or determine the cause of the reported event.All rt202 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt202 adult inspiratory heated breathing 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.".
Event or Problem Description
A healthcare facility in the united kingdom reported that a rt202 adult inspiratory heated breathing circuit was found leaking droplets of water from the connection of the inspiratory chamber port.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).**udi related data quality updates only** corrections to reflect gudid: section d1: brand name updated to fisher & paykel healthcare section d2a: common device name updated to breathing circuit section d4: expiration date added section d4: udi details updated section g1: contact person updated to (b)(4).Section g4: the rt202 adult dual heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112 method: the subject rt202 adult inspiratory heated breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is thus based on the information and video provided by the customer and our knowledge of the product.Results: the customer reported that a rt202 adult inspiratory heated breathing circuit was found leaking from the connection of inspiratory chamber port.Conclusion: the subject rt202 adult inspiratory heated breathing circuit was requested to be returned for evaluation; however, it was not provided.Without the return of the subject device, we are unable to confirm a fault, or determine the cause of the reported event.All rt202 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt202 adult inspiratory heated breathing 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.".

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18361450
• Report Number: 9611451-2023-01190
• Device Sequence Number: 15396402
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2102553359(11)230324(17)280324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K983112
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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: Lay User/Patient
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2102553359
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/02/2024; 02/02/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/27/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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
• Patient Sex: Male