MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. SPARQ DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problem Failure to Power Up (1476)

Patient Problem Death (1802)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

During this critical trauma code, the ultrasound machine in trauma would not turn on.It flashed on once then would not turn on.We needed to check for damage to the aorta, heart wall motion, cardiac tamponade, etc.This patient expired and we were not able to give the best care possible.

• Brand Name: SPARQ DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 7167214
• MDR Text Key: 96463349
• Report Number: 7167214
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2017

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: No Information
• Other Device ID Number: CEID 966452
• 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: 11/28/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1