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 12/17/2016

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 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.Investigation: the root cause for the system shutdown during mid-exam was investigated.The cause of the problem was that a techncal evalaution of the original issue could not be performed as the software was reinstalled without collecting logs.So there were no logs or screenshots available for technical investigation.The final solution was the addition of a service tool was for a future software release of the sc2000 ultrasound systems to help diagnose the motherboard.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 and fu#1.

Event Description

It was reported that the ultrasound system booted with blue window screen indicating the operating system had failed to start.No additional information was provided.Multiple attempts were made to obtain additional information regarding the reported phenomenon and patient outcome but with no results.

• 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: 6530173
• MDR Text Key: 283321588
• Report Number: 3009498591-2017-00022
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2021

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2016
• Initial Date FDA Received: 04/28/2017
• 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: Reuse
• Patient Sequence Number: 1