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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 RT266
Device Problems Disconnection (1171); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2020
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 distributor in hospital reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the rt266 infant dual-heated evaqua2 breathing circuit swivel was found disassembled.There was no reported patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the complaint device was not returned, however 88 sealed rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of event and the evaluation of the 88 sealed rt266 breathing circuits and our knowledge of the product.Results: the swivel elbows and swivel wyes of all 88 returned rt266 breathing circuits were found fully assembled.Conclusion: without the complaint device, we could not determine what caused the rt266 swivel to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.The rt266 infant dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt266 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 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.'.
 
Event Description
A distributor in hospital reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the rt266 infant dual-heated evaqua2 breathing circuit swivel was found disassembled.There was no reported patient consequences.
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9724190
MDR Text Key183954613
Report Number9611451-2020-00163
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,distri
Type of Report Initial,Followup
Report Date 01/20/2020
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 NumberRT266
Device Catalogue NumberRT266
Device Lot Number2100846900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Initial Date Manufacturer Received 01/20/2020
Initial Date FDA Received02/18/2020
Supplement Dates Manufacturer Received03/11/2020
Supplement Dates FDA Received04/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2019
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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