MAUDE Adverse Event Report: NON-HEATED ADULT BREATHING CIRCUIT; BTT

Model Number	RT134
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ps340124.The complaint rt134 adult breathing circuit is currently en routee to fisher & paykel healthcare in new zealand for investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) that an rt134 adult breathing circuit did not pass the ventilator leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
Ps340124.Method: the complaint rt134 non-heated adult breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation where it was visually inspected.Results: visual inspection revealed that the top of the water bowl was found to be broken.Conclusion: the reported event is likely as a result of the broken water bowl.We are unable to determine the cause of the broken water bowl.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 rt134 adult 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 japan that an rt134 adult breathing circuit did not pass the ventilator leak test before use.There was no patient involvement.

• Brand Name: NON-HEATED ADULT BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 10141431
• Report Number: 9611451-2020-00530
• Device Sequence Number: 11323006
• Product Code: BTT
• UDI-Device Identifier: 09420012430533
• UDI-Public: 010942001243053310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: RT134
• Device Catalogue Number: RT134
• Device Lot Number: 2100796519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/23/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2019
• 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