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

Model Number	RT125
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt125 infant bias flow breathing circuit was returned to fph in (b)(4) for investigation where it was visually inspected and pressure tested.Results: visual inspection revealed a crack along one of the swivel wye ports.The pressure test result was outside of specification.Conclusion: we were 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 circuit would have met the required specifications at the time of 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)(6) reported via a fisher & paykel healthcare (fph) field representative that a crack was found on the swivel wye of an rt125 infant bias flow breathing circuit.This was discovered before patient use.

• Brand Name: INFANT BIAS 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: 6459146
• Report Number: 9611451-2017-00299
• Device Sequence Number: 563251
• Product Code: BTT
• UDI-Device Identifier: 09420012431141
• UDI-Public: (01)09420012431141(10)2100087349(11)160927
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: 2100087349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1