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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); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint device is currently en route to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the rt265 infant dual-heated evaqua2 breathing circuit swivel was found disassembled during patient use.There was no reported patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare for evaluation.Results: visual inspection of the returned complaint device revealed that the swivel elbow and swivel wye was returned disassembled.Damage was observed to the swivel wye of the complaint device.The swivel elbow and swivel wye were reassembled and the pressure test confirmed a tight 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 rt266 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.".
 
Event Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the rt265 infant dual-heated evaqua2 breathing circuit swivel was found disassembled during patient use.There was no reported patient consequences.
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9485444
MDR Text Key181538450
Report Number9611451-2019-01221
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,foreig
Type of Report Initial,Followup
Report Date 11/21/2019
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
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Device Lot Number2100830382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2019
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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