MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

This issue is under investigation.A follow-up report will be submitted when the investigation results are available.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.

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.Siemens medical solutions usa, inc.Received a medwatch report # (b)(4) reporting the following: " as the ultrasound tech was performing the ultrasound and the machine shut off during the exam.The ultrasound had to be unplugged from the power cord in order to shut it off and be able to turn it back on to continue the case.This same scenario has happened 3 times in the last 2 days and we are waiting for the manufacturer to come out today to asses the problem.They also had replaced the hard drive in this unit on (b)(6) 2015, because the machine would not boot up." siemens followed up with the event reporter at the user facility and it was reported that the issue happened on multiple patients.The user facility believes that the cause is due to equipment issue that also contributed to delayed patient care.There was no patient adverse event reported.No additional information was provided.

• Brand Name: ACUSON S2000 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: 6395437
• MDR Text Key: 281533416
• Report Number: 3009498591-2016-00273
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

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 S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2015
• Initial Date FDA Received: 03/10/2017
• 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