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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 Loss of Data (2903)
Patient Problem Insufficient Information (4580)
Event Date 02/24/2016
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 1 narrative: this supplemental report is being submitted to provide additional event information, and to provide the date new information was received. 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 as a follow-up to the original mdr submitted 10/03/2016. Additional information was received and it was reported that after an unknown procedure, it was found that the images were lost and were unrecoverable. The procedure was repeated. There was no patient or user injury reported. No additional information was provided. Follow-up narrative 2: 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: during the investigation of the complaint, the possible cause of the system loosing images when ending exam was a result of the user inadvertently deleting images from the review screen prior to ending the exam. This issue was resolved through the service process. Note: the original emdr was submitted to the non-production environment. This report is to submit to the production environment. This emdr contains both the initial submission, fu#1 and fu#2.
 
Event Description
It was reported that at the conclusion of the study, the patient's images were lost. 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.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional event information and to provide the date new information was received.
 
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 as a follow-up to the original mdr submitted 10/03/16. Additional information was received and it was reported that after an unknown procedure, it was found that the images were lost and were unrecoverable. The procedure was repeated. There was no patient or user injury 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
Manufacturer Contact
khalil thomas
business area ultrasound
22010 se 51st street
issaquah, WA 98029
4253929180
MDR Report Key6443179
MDR Text Key282963501
Report Number3009498591-2016-00365
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2016
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 S2000
Device Catalogue Number10041461
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/07/2016
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

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