MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER

Model Number PX260

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/14/2014

Event Type  Injury  

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¿.

Manufacturer Narrative

We received one single dpt kit.Examination revealed that a section of the dpt cable cover appeared to be burned and melted.The burn section was approximately 1" in length and 1" proximal from the dpt housing.It was also noted that the number 5 leadwire was exposed at the burned area.The cable cover turned black at the center of the burn and brown in the area surrounding the burned mark.Further examination revealed that the cable turned to a 90 degree angle at the burned area.However, x-rays showed that the leadwires were intact.The leadwire maintained separated from one another and no short condition between the leadwires at the burn area was observed.The x-rays also showed that the rest of the dpt circuit, which includes the dpt cable connector, cable and the sensor chip were intact and there was no short condition.It was also revealed that the dpt zeroed and sensed pressure accurately on the pressure monitor.The electrical testing also showed that the dpt electronic components were intact because both input impedance and output impedances were within specifications.Additionally, as stated on the edward's website, these devices and their associated cables are not intended for use inside the bore of the mr system and should not be in contact with the patient during the mr procedure.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: DISPOSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3622639
• MDR Text Key: 16912554
• Report Number: 2015691-2014-00298
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: PX260
• Device Lot Number: 59607400
• Was Device Available for Evaluation?: Yes
• 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: Initial
• Patient Sequence Number: 1