MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER

Model Number T001658A

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that there was a disconnection at the three way valve.This was a pediatric patient.The clinician noticed the disconnection immediately and secured the connection.There was no harm or injury to the patient.No further clinical information is available.

Manufacturer Narrative

The product was not returned for evaluation as it was discarded at the hospital.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The complaint could not be confirmed without a product return, nor could potential contributing factors be identified.No further actions will be taken at this time.

• 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: 3872275
• MDR Text Key: 19802166
• Report Number: 2015691-2014-01382
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001658A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• 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