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

Model Number ACUSON X700 100V/115V/230V WW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Delayed Program or Algorithm Execution (4034)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report is resubmitted on request by the fda to correct field to initial report.

Event Description

Previously submitted.

Manufacturer 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.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 respond when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.

Event Description

Additional information was received and it was reported that during a transesophageal echocardiography (tee) ultrasound procedure, the system locked up with color and upon entering cw doppler.There was no error message observed.The system was rebooted to recover from the event.The procedure was completed with no loss of data and the system only needed to be rebooted to resume the procedure.There was no patient or user injury reported.No additional information was provided.

Manufacturer Narrative

During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.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 respond when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.(b)(4).This report is resubmitted on request by the fda to the production environment.

Manufacturer Narrative

During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.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 respond when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.This report is resubmitted on request by the fda.

Event Description

Additional information was received and it was reported that during a transesophageal echocardiography (tee) ultrasound procedure, the system locked up with color and upon entering cw doppler.There was no error message observed.The system was rebooted to recover from the event.The procedure was completed with no loss of data and the system only needed to be rebooted to resume the procedure.There was no patient or user injury reported.No additional information was provided.

• Brand Name: ACUSON X700 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view, ca WA 98029
• MDR Report Key: 6312745
• MDR Text Key: 198518344
• Report Number: 3009498591-2016-00173
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K141846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2016

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 X700 100V/115V/230V WW
• Device Catalogue Number: 10658844
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: 06/14/2016; 06/14/2016; 06/14/2016
• Supplement Dates FDA Received: 05/05/2021; 02/08/2017; 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1