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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CORPORATION TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP
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EDWARDS LIFESCIENCES CORPORATION TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number TRUWAVE 3CC/60, 150CM
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem Burn(s) (1757)
Event Date 01/13/2014
Event Type  Injury  
Event Description
Patient with edwards truwave pressure monitoring kit in use-arterial blood pressure monitoring.Model-truwave 3cc/60, 150cm, reference number px260 (kit), lot number 59607400.This kit contains model px600f disposable transducer, flush device, iv macrodrip set-up, 48 & 12 inch pressure tubing, & 2 three-way stopcocks.The px600f label states "conditional" compatibility with mri (inside bore.) mri study discontinued when odor/burn noted.Transducer cable was burnt and where it rested on the patient's rue (right upper extremity) was burnt.It was thought that the entire "kit" was safe for use within the mri unit.The exact wording/label of the kit is pending.
 
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Brand Name
TRUWAVE
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES CORPORATION
one edwards way
irvine CA 92614
MDR Report Key3594415
MDR Text Key19587125
Report Number3594415
Device Sequence Number1
Product Code DXO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberTRUWAVE 3CC/60, 150CM
Device Catalogue NumberPX260 (KIT)
Device Lot Number59607400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2014
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2014
Event Location Hospital
Date Report to Manufacturer01/28/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2014
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; DISPOSABLE TRUWAVE TRANSDUCER
Patient Outcome(s) Other; Required Intervention;
Patient Age64 YR
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