MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. EPIQ 7C ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 795201

Patient Problem Discomfort (2330)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Cardiac us machine froze in the middle of icu exam and had to be shut down and rebooted.Patient was in icu, intubated, and had difficulty tolerating exam.Exam time was extended to this equipment failure.This is not a first occurrence.Manufacturer response for cardiac us machine, phiips cardiac us machine (per site reporter).Unknown at this time.

• Brand Name: EPIQ 7C ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 19087316
• MDR Text Key: 339907404
• Report Number: 19087316
• 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: 01/08/2024,12/14/2023

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
• Device Model Number: 795201
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1