MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number	RT202
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
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 in colombia reported via a fisher & paykel healthcare (f&p) field representative that a rt202 adult inspiratory heated breathing circuit was found cracked.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt202 adult inspiratory heated breathing circuit was not returned to f&p for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a rt202 adult inspiratory heated breathing circuit was found cracked.Conclusion: without the complaint device, we are unable to confirm 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 infant 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 state 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 before use and replace if damaged.".
Event or Problem Description
A disitributor in colombia reported via a fisher & paykel healthcare (f&p) field representative that a rt202 adult inspiratory heated breathing circuit was found cracked.There was no reported patient involvement.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Common Device Name: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14431700
• Report Number: 9611451-2022-00470
• Device Sequence Number: 5133111
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2101670412(11)210609
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2101670412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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