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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problems Disconnection (1171); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device lot number: 2100809308, d.O.M: (b)(6) 2019.Device lot number: 2100800481, d.O.M: (b)(6) 2019.Device lot number: 2100801533, d.O.M: (b)(6) 2019.The complaint devices rt265 infant dual heated evaqua2 breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that three rt265 infant dual-heated evaqua2 breathing circuit failed the pressure test during set-up.There were no patient involvement.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that three rt265 infant dual-heated evaqua2 breathing circuit failed the pressure test during set-up.There were no patient involvement.
 
Manufacturer Narrative
(b)(4).Device 1, 5 and 6: lot unknown.Device 4 lot number: 2100809308, d.O.M: 28 june 2019.Device 2 lot number: 2100800481, d.O.M: 19 june 2019.Device 3 lot number: 2100835013, d.O.M: 25 july 2019.Method: the swivels of complaint rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and pressure tested.Results: device 1: the swivel elbow and swivel wye were returned partly disassembled.Damages was observed to the swivel wye.The swivel elbow and swivel wye were reassembled.The pressure test for the complaint device confirmed a tight fit of swivel components.Device 2 & 4: the swivel elbow and swivel wye were returned assembled.No damages were observed to any of the swivel components.The pressure test for the complaint device confirmed a tight fit of swivel components.Device 3, 5, 6: the swivel elbow and swivel wye were returned assembled.No damages were observed to any of the swivel components.The pressure test for the complaint device confirmed a loose fit of swivel components.Conclusion: investigation into this complaint reviewed the manufacturing process (operator, equipment, measurement and environment), process documentation, samples of product, complaint devices and performed a material analysis.The investigation indicated a potential resin material mix-up was the most likely cause.We have since implemented an additional material verification step, at the point of resin material addition to the moulding machine feed.This verification would identify any potential resin material mix-up prior to use.All rt265 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit 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.".
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9254032
MDR Text Key178352143
Report Number9611451-2019-01040
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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