MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCE PRESSURE MONITORYING SYSTEM; TRANSDUCER, PRESSURE, CATHETER TIP

Lot Number 63280173

Device Problem Flushing Problem (1252)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

Art line not flushing properly square wave not square.Cvp line square wave appropriate within same set up.Tubing changed out and both have appropriate square waves.Fda safety report id # (b)(4).

• Brand Name: EDWARDS LIFESCIENCE PRESSURE MONITORYING SYSTEM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 11108239
• MDR Text Key: 225173102
• Report Number: MW5098636
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 63280173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1