MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. TRANSDUCER X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number X8-2T

Device Problem Defective Device (2588)

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

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Tee scope not working in port 2 of echo machine.

• Brand Name: TRANSDUCER X8-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 15445482
• MDR Text Key: 300146847
• Report Number: 15445482
• Device Sequence Number: 1
• Product Code: ITX
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X8-2T
• Device Catalogue Number: 989605455171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1