MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT BIAS FLOW BREATHING CIRCUIT; BZE

Model Number	RT125
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt125 infant bias flow breathing circuit, was returned to (b)(4) in (b)(4) for investigation where it was pressure tested and submerged in a water bath to test for leaks.Results: a pressure test revealed that the circuit was outside of specification.A waterbath test showed that the location of the leak was at the swivel duckbill.Conclusion: we are unable to determine what may have caused the reported complaint.All rt125 infant breathing circuits are visually inspected and pressure and flow tested prior to distribution, and those that fail are rejected.The subject rt125 infant breathing circuits would have met the required specifications at the time of production.This suggests the leak occurred post production.The user instructions that accompany the rt125 infant bias flow 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 hospital in (b)(4) reported via a distributor that the rt125 infant bias flow breathing circuit did not pass the initial leak test of the ventilator when checked before use.The medical engineer noticed the air leak was at the duck bill.No patient consequence was reported.

• Brand Name: INFANT BIAS FLOW BREATHING CIRCUIT
• Common Device Name: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• MDR Report Key: 6337754
• Report Number: 9611451-2017-00102
• Device Sequence Number: 868835
• Product Code: BZE
• UDI-Device Identifier: 09420012431141
• UDI-Public: (01)09420012431141(10)2100074904(11)160822
• 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): 01/18/2017

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: RT125
• Device Catalogue Number: RT125
• Device Lot Number: 2100074904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1