MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX1800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/14/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the reported customer complaint regarding the potential product failure of the px1800 truwave cable (with the use of transducer kit on a patient having an mri triggering a 3rd degree burn on the patients right forearm) was not confirmed.Upon investigation, the cable was tested for continuity using a calibrated multimeter testing equipment.The cable passed the continuity by testing all the wire connections between one end to the other.There was no physical damage noted on the cable.

Event Description

It was reported that one of our transducer kits was used on a patient having an mri.The monitoring system used was an invivo system and cable.The dpt kit was used while the mri procedure was performed.It was further stated that the line was taped down but not at the patient¿s arm.It is believed that whatever caused the burn must have jumped to the arm through an electric arc or spark from the cable.This incident triggered a 3rd degree burn on the patient¿s right forearm, the size of a cigar end.The incident caused a burn to occur on the white connector cable ¾¿ from the transducer.The burn length on the cable itself is approximately 3/4¿.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3627250
• MDR Text Key: 17717058
• Report Number: 2015691-2014-00342
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PX1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• 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: Reuse
• Patient Sequence Number: 1