MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Model Number T001631A

Device Problem High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

It was reported that the device was attached to the patient and the dpt was overestimating the pressure readings.It was not possible to zero the dpt.The dpt indicated the pressure was 170 mmhg.Map indicated 140 mmhg when the expected value was 60 mmhg.Antihypertensive treatment was administered to the patient, but when the medical team realized that the pressure indicated on the monitor did not decrease, the dpt was changed out.The new pressure measured on the monitor was 50mmhg.No further information is available at this time.

Manufacturer Narrative

One single dpt kit was received for evaluation.The examination revealed that the dpt did zero and sense pressure accurately on the pressure monitor.The pressure readings were stable.The pressure readings did not drift during the drift test.The electrical testing showed that the dpt electronic components were intact because both input and output impedances were within specifications.There was no leakage or occlusion detected from the kit during the pressure test.There was no visible defect observed from the kit.A device history record review was completed and it was confirmed that the device met specification upon distribution.The complaint could not be confirmed during evaluation.There is no indication of a manufacturing defect that was noted during the analysis.It could not be determined if any clinical or procedural factors may have contributed to the event.No actions will be taken at this time.

• Brand Name: TRUWAVE 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: 3857522
• MDR Text Key: 4683168
• Report Number: 2015691-2014-01331
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001631A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• 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