MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number EPIQ7C

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Information (3190)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

Ultrasound imaging system (philips epiq 7c) reported error during fetal echocardiography scan indicating there was a problem storing images.Moments later a second error message was displayed with an error code (recorded and given to biomedical engineering).The system needed to be restarted in the middle of the exam.It was determined that several images prior to the error had been corrupted and could not be transferred to the pacs system and needed to be repeated.The technologist performing the exam started a new exam, repeating the required images and completed the exam with follow-up images obtained by the attending cardiologist according to protocol.The exam was then merged with the initial images acquired prior to the error messages.

• Brand Name: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 7804286
• MDR Text Key: 117848961
• Report Number: 7804286
• Device Sequence Number: 1
• Product Code: IYN
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EPIQ7C
• 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: 07/31/2018
• Date Report to Manufacturer: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA