MAUDE Adverse Event Report: ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number	RT205
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The rt205 adult inspiratory 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 complaint rt205 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation, where it was pressure tested.Results: pressure testing revealed that the circuit was out of specification.The water bath test revealed that the leak was through the connection between the lid and bowl of the water trap.Conclusion: we are unable to determine the cause of the reported event.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt205 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.Set appropriate ventilator alarms.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative, that a rt205 adult inspiratory heated breathing circuit failed the leak test prior to patient use.There was no patient involvement.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 10287425
• Report Number: 9611451-2020-00625
• Device Sequence Number: 16358765
• Product Code: BTT
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2101067334(11)200405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: RT205
• Device Catalogue Number: RT205
• Device Lot Number: 2101067334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2020
• 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