• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON SC2000
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Insufficient Information (4580)
Event Date 03/07/2016
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 (see h2), update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results. Investigation: during the investigation of the complaint, it was noted that the customer service engineer had reloaded the software. As a result, the error logs were not available for the investigation; the reported issue could not be reproduced during in-house testing. Therefore, the root cause of this complaint could not be investigated. 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
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 while the sonographer was scanning, the ecg flat-lined and then the system locked up. The system was rebooted and the system recovered and operated normally. No additional information was provided. We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of a potential adverse event and without patient outcome information. Should we receive further information in regards to this report, we will file a follow-up report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACUSON SC2000 ULTRASOUND SYSTEM
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
business area ultrasound
22010 se 51st street
issaquah WA 98029
MDR Report Key6443393
MDR Text Key282774805
Report Number3009498591-2016-00371
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUSON SC2000
Device Catalogue Number10433816
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
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

-
-