MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IU22 DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 8500-0064-02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  malfunction  

Event Description

Sonographer turned on the machine only to receive "error message".Machine was rebooted and same error occurred.

• Brand Name: IU22 DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 3000 minuteman road; building 4; andover MA 01810
• MDR Report Key: 8335555
• MDR Text Key: 136070872
• Report Number: 8335555
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8500-0064-02
• 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: 01/04/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8030 DA