MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. EPIQ 5; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number EPIQ 5

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

During operation of the device, error during exam halted the exam.Color and doppler froze during exam.

• Brand Name: EPIQ 5
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 10829009
• MDR Text Key: 215934102
• Report Number: 10829009
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 5
• 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: 09/29/2020
• Device Age: 5 YR
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1