MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IE33 DIAGNOSTIC ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 8500-0082-01

Device Problems Loss of Power (1475); Device Stops Intermittently (1599)

Patient Problem No Information (3190)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

Ultrasound monitor intermittently blacks out; monitor is turned back on and it will shut off.Repeat issue.Monitor replaced 3 months ago and video cards replaced 5 months ago.

• Brand Name: IE33 DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 3000 minuteman road; andover MA 01810
• MDR Report Key: 6934391
• MDR Text Key: 88865691
• Report Number: 6934391
• Device Sequence Number: 1
• Product Code: ITX
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8500-0082-01
• 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: 09/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1