MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2016

Event Type  malfunction  

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.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.Background: - the issue was created in 4.0c as a side effect of a 4.0c enhancement to remove an informational message on tee probes.- prior to 4.0c, when tee probes reached 40 deg c, a popup message was displayed to inform the user the transducer temperature was rising.- on z6ms probes, the customer complained that this message was undesirable and confusing as it was assumed to be a warning message and not just informational.It was requested to be removed.Root cause: - in the 4.0c release, when the popup message was removed, the sw changes did not cover one behavior interaction with the mouse cursor.- in previous versions of sw, when the popup message was displayed, it contained an "ok" button for the user to dismiss the message.To enable the user to interact with the "ok" button, the sw provided the user with a mouse pointer.This was fixed as an engineering defect for release vb10d (4.0d) which corrects the issue, via update program us014/16/s.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial submission, fu#1 and fu#2.

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 there was an intermittent issue regarding the transducer.When it is moved in 4d mode, the cd box works; however, when switched to 2d mode, it won't move.When going back into 4d mode, the cd box can't be moved.Reportedly, the system need to be rebooted to recover.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• 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: 6292775
• MDR Text Key: 283506982
• Report Number: 3009498591-2016-00378
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K142628
• 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
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1