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U.S. Department of Health and Human Services

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

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
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.
 
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Brand NameACUSON S2000 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 Key6395437
MDR Text Key281533416
Report Number3009498591-2016-00273
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K140959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUSON S2000
Device Catalogue Number10041461
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
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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