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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); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint device is currently en route to fisher & paykel healthcare (f&p) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in (b)(6) reported that a swivel of rt266 infant dual heated evaqua2 breathing circuit came apart.There was no reported patient involvement.
 
Manufacturer Narrative
(b)(4).Section d10 amended to "no" as device was not returned for evaluation.Method: the complaint (b)(4) infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of event and our knowledge of our product.Conclusion: the customer reported that a swivel of rt265 infant dual heated evaqua2 breathing circuit came apart.Without the complaint device, we could not determine what caused the rt265 swivel to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.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 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 healthcare facility in louisiana reported that a swivel of rt266 infant dual heated evaqua2 breathing circuit came apart.There was no reported patient consequence.
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9508130
MDR Text Key181958499
Report Number9611451-2019-01240
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 health professional,user faci
Type of Report Initial,Followup
Report Date 11/22/2019
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 NumberNOT PROVIDED
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/22/2019
Initial Date FDA Received12/21/2019
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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