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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER AND PAYKEL EVAQUA2; BREATHING CIRCUIT
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FISHER AND PAYKEL EVAQUA2; BREATHING CIRCUIT Back to Search Results
Model Number RT 265
Device Problem Overheating of Device (1437)
Patient Problems Tachycardia (2095); Increased Respiratory Rate (2486); Alteration In Body Temperature (2682)
Event Date 10/16/2014
Event Type  Injury  
Event Description
Birthing ga: (b)(6).Cga: (b)(6) infant receiving neonatal intensive care intubated and ventilated currently receiving heliox therapy via mechanical ventilation utilizing fisher and paykel disposable infant ventilator circuit.Product info as follows; fisher and paykel respiratory care system evaqua2 ref # rt265 lot number 140801.This circuit overheated, very hot to touch.Pt heart rate increased to 193bpm, respiratory rate increased to 96 bpm and core temperature of 38 c.Power to circuit disabled, circuit was replaced, pt returned to baseline hr, rr and temperature.We were very concerned this disposable circuit was about to melt.Dates of use: (b)(6) 2014.Diagnosis or reason for use: life support mechanical ventilation for critically ill pt.Event abated after use stopped or dose reduced?: yes.
 
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Brand Name
EVAQUA2
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
FISHER AND PAYKEL
MDR Report Key4192854
MDR Text Key5102548
Report NumberMW5038705
Device Sequence Number1
Product Code BZE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT 265
Device Catalogue NumberRT 265
Device Lot Number140801
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 DA
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