MAUDE Adverse Event Report: PHILIPS ULTRASOUND LLC. X5-1C TRANSDUCER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 989606702251

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

Philips ultrasound x5-1c transducer is giving a error message and is not "detectable" on any of the epic machines.Plugged the probe in to all the epic machines and received the same error message.Philips diagnosed and sent replacement probe.

• Brand Name: X5-1C TRANSDUCER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND LLC.; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 18228773
• MDR Text Key: 329260584
• Report Number: 18228773
• Device Sequence Number: 1
• Product Code: IYO
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 989606702251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Date Report to Manufacturer: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1