MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. TRANSDUCER C5-1; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

While imaging, ultrasound philips epiq c5-1 curved transducer demonstrated horizontal artifact on grayscale imaging.On color image, the artifact appears pixel like.Transducer removed from service.Study completed with different probe.

• Brand Name: TRANSDUCER C5-1
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 12518663
• MDR Text Key: 272954821
• Report Number: 12518663
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2021

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1