MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X700 ULTRASOUND SYSTEM

Model Number ACUSON X700

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2016

Event Type  malfunction  

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that during a long and difficult transesophageal echocardiography (tee) examination, the ultrasound system crashed with a display of us_img_57 error message.The system made a beeping sound and the sonographer performed a hard shut-down.The images taken were reportedly stored.There is no report of the patient's outcome.No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of a potential adverse event and without patient outcome information.Should we receive further information in regards to this report, we will file a follow-up report.

Manufacturer Narrative

Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up #1 narrative: this supplemental report is being submitted to provide additional event information, provide the date new information was received, and update the patient code.As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/03/16.Additional information was received and it was reported that the transesophageal echocardiography (tee) study was not repeated.The same equipment was used to complete the study.There was no patient injury reported.No additional information was provided.Follow-up #2 narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.And the software may not detect any response from the v5ms transducer in a given time period in cw mode, since it would take a longer time to take response when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial submission, fu#1 and fu#2.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information, provide the date new information was received, and update the patient code.

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/03/16.Additional information was received and it was reported that the transesophageal echocardiography (tee) study was not repeated.The same equipment was used to complete the study.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation (see d10), update the follow-up type (see h2), update the device evaluated by manufacturer (see h3), update the event problem and evaluation codes (see h6), and provide the investigation results.During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.And the software may not detect any response from the v5ms transducer in a given time period in cw mode, since it would take a longer time to take response when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.

• Brand Name: ACUSON X700 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 6312198
• MDR Text Key: 283260055
• Report Number: 3009498591-2016-00366
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON X700
• Device Catalogue Number: 10658844
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• 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: Reuse
• Patient Sequence Number: 1