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

Model Number PX284R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

Patient developed a pressure injury on the lateral right thumb due to compression from the arterial line tubing.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6776670
• MDR Text Key: 82138564
• Report Number: 6776670
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/03/2017

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: No Information
• Device Model Number: PX284R
• Device Catalogue Number: PX284R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 3 YR