MAUDE Adverse Event Report: INFANT LOW FLOW BREATHING CIRCUIT; BZE

Model Number RT226

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One of the complaint devices is currently en route to fisher & paykel healthcare (f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher & paykel healthcare (f&p) field representative that a cap of two rt226 infant low flow breathing circuits is falling off during set up.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that a cap of two rt226 infant low flow breathing circuits is falling off during set up.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: both the complaint rt226 infant low flow breathing circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of the event, photographs provided and our knowledge of the product.Results: visual inspection of the photographs provided by the customer shows that the swivel elbow and wye have disassembled.Conclusion: without the complaint device, we could not determine what caused the rt226 circuits swivels to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.The rt226 infant low flow breathing circuits are designed to conform to iso:5367.All rt226 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt226 infant low flow breathing circuits also 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.".

• Brand Name: INFANT LOW FLOW BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9541881
• MDR Text Key: 182330036
• Report Number: 9611451-2020-00010
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2100763250, NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1