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U.S. Department of Health and Human Services

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

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
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.
 
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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 Key6530173
MDR Text Key283321588
Report Number3009498591-2017-00022
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 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2017
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 Received12/17/2016
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

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