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

Model Number RX6001

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 09/27/2018

Event Type  malfunction  

Event Description

Patient was traveling to ir with rn.Evd broke while traveling.It is thought that the transducer is breaking at the connection to the catheter that connects to the patient.Break may be caused by a combination of the user twisting the connection too tight and/or the weight of the cords hanging from one side of the transducer may be causing a weakness at the connection site.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7990271
• MDR Text Key: 124520046
• Report Number: 7990271
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RX6001
• Device Catalogue Number: INS1100
• Device Lot Number: 60975581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12775 DA