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

Model Number PX284

Device Problem Output Problem (3005)

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

Event Date 01/10/2020

Event Type  malfunction  

Event Description

Arterial line set up primed with saline to use to monitor the bp.Not working, had to disconnect supply and prime another arterial line set up.Now able to monitor arterial bp.The arterial line set up thet malfunctioned was returned to materials management.

• 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: 9852901
• MDR Text Key: 184120429
• Report Number: 9852901
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2020

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 Model Number: PX284
• Device Catalogue Number: PX284
• 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: 02/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 DA
• Patient Weight: 2