MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT LOW FLOW BREATHING CIRCUIT; BTT

Model Number	RT226
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt226 infant low flow breathing circuit was received at fisher & paykel healthcare (b)(4) for investigation.The subject circuit was visually inspected.Results: the watertrap end connector of the short expiratory tube was found disconnected.No damage was found to the connector or the tube cuff.Conclusion: we are unable to determine the cause of this complaint.All rt226 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt226 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 hospital in (b)(6) reported via our distributor that an rt226 infant low flow breathing circuit failed the initial leak test of the servo-i ventilator.They also noticed an air leak from the connection between the expiratory limb and the water trap.There was no patient involvement.

• Brand Name: INFANT LOW FLOW BREATHING CIRCUIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7804054
• Report Number: 9611451-2018-00702
• Device Sequence Number: 11041903
• Product Code: BTT
• UDI-Device Identifier: 09420012431165
• UDI-Public: (01)09420012431165(10)2100288611(11)170811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020332
• 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
• Report Date (Section B): 07/23/2018

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: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2100288611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1