Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT266
Device Problems Disconnection (1171); Overheating of Device (1437)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that the swivel of the rt266 infant dual-heated evaqua2 breathing circuit was found to be disassembled during patient use.The patient desaturated with bradycardia.There was no further patient consequences reported.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt266 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 the event, a photograph provided and our knowledge of our product.Results: visual inspection of the photograph 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 rt266 swivel to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.The rt266 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All 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 healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that the swivel of the rt266 infant dual-heated evaqua2 breathing circuit was found to be disassembled during patient use.The patient desaturated with bradycardia.There was no further patient consequences reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9731316
MDR Text Key183958728
Report Number9611451-2020-00173
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,user f
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
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 NumberNOT PROVIDED
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2020
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
-
-