MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE,

Model Number ACUSON SC2000

Device Problems Computer Operating System Problem (2898); Loss of Data (2903)

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

Event Date 03/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device is undergoing an evaluation but has not yet been completed.

Event Description

The investigation revealed that the system locked-up with a blue screen.Patient's studies are lost and studies need to be repeated.It can happen at any time, including during an exam.The user would be required to reboot, but also the images may not have transferred due to the loss of the wi-fi connection.

Manufacturer Narrative

Investigation: the problem was resolved after replacement of the wireless dongle and control panel, and the issue had not recurred since.The returned parts were not investigated for repair.This issue was solved through the service process.

Manufacturer Narrative

Investigation: the system logs were reviewed, and the issue was not found.After reporting the issue, the customer changed the workflow by switching to "end of exam" transfer.On a later date, the customer service engineer reported that the system had seen the issue again since the original occurrence.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE,
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view 94043
• Manufacturer Contact: karen smith
• MDR Report Key: 5603659
• MDR Text Key: 43777837
• Report Number: 3009498591-2016-00097
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2017

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: Health Professional
• Device Model Number: ACUSON SC2000
• Device Catalogue Number: 10433816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1