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

Model Number SC2000

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation results: this supplemental report is being submitted to update the manufacturer contact phone number; provide the date new information was received by manufacturer; provide the type of report; provide the type of reportable event; provide the type of follow-up; update th the event problem and evaluation codes; provide the remedial action initiated; provide the correction/removal reporting number; and provide additional manufacturer narrative.The device referenced in this report was not returned to siemens for investigation.Engineering had the issue created in 4.0c as a side effect of a 4.0c enhancement to remove an informational message on transesophageal echocardiography (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.When the message was removed, the sw was not completely changed to remove this behavior of providing the mouse pointer.This issue was fixed in software release vb10d (4.0d).

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 transesophageal echocardiography (tee) procedure, the system lost control of the roi or strip mode cursor when imaging with the tee probe.The system had to be restarted in order to continue the procedure.There was a delay of 25 minutes as the reported phenomenon occurred more than once.There was no loss of patient data.There was no patient injury reported.No additional information was provided.

• Brand Name: ACUSON SC2000
• Type of Device: DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view, ca
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view, ca
• Manufacturer Contact: christine dunn ; 22010 se 51st st; issaquah, wa ; 7851617
• MDR Report Key: 7679402
• MDR Text Key: 199239606
• Report Number: 3009498591-2016-00383
• Device Sequence Number: 1
• Product Code: IYN
• 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: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2000
• Device Catalogue Number: 10433816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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