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

Model Number	RT226
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt226 was received at our fisher & paykel healthcare (fph) regional office in (b)(4) and was visually inspected by trained fph personnel.Results: visual inspection revealed a crack along one of the swivel wye ports of the subject circuit.Conclusion: investigations into this issue have determined that the cracking has most likely occurred due to improperly mixed material in the batch.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.We anticipate that this will resolve the issue and the project to implement this change is currently in process.All rt266 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 the rt226 infant low flow breathing circuit had a crack on the swivel.There was no patient involvement.

• Brand Name: INFANT LOW FLOW BREATHING CIRCUIT
• Common Device Name: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 6823320
• Report Number: 9611451-2017-00775
• Device Sequence Number: 11072550
• Product Code: BZE
• UDI-Device Identifier: 09420012431165
• UDI-Public: (01)09420012431165(10)2100134019(11)170116
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2100134019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1