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

Catalog Number PX6001

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/27/2014

Event Type  malfunction  

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARD LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 4562167
• Report Number: 4562167
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/30/2014

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: Nurse
• Device Catalogue Number: PX6001
• Device Lot Number: 59566079
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2014
• Event Location: Other
• Date Report to Manufacturer: 03/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Patient Sequence Number: 1
• Patient Age: 75 YR