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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S3000 ULTRASOUND SYSTEM ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S3000 ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON S3000
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2016
Event Type  malfunction  
Event Description
It was reported that the keyboard bezel has a large crack with a sharp edge near the dgc panel. 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 the potential adverse event before we have received patient outcome information. Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information. Should we receive further information in regards to this event, we will file a follow-up report.
 
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 provide the date new information was received. Additional information was received and it was reported that the phenomenon was noted during equipment testing/preventative maintenance. There was no study being performed so there was no patient involvement. No additional information was provided. Follow-up #2 narrative: this supplemental report is being submitted to provide the date new information was received by manufacturer and provide the type of report; provide the type of reportable event; provide the type of follow-up, and update the event problem and evaluation codes; and provide the investigational results. The device referenced in this report was not returned to siemens for investigation; however, the customer service engineer (cse) was onsite and visually saw that the bezel was cracked. The cse replaced the defective bezel. The control panel cracking was attributed to the product design. It was addressed with a design change to the plastic components of the control panel, implemented in october 2016. (b)(4). Note: the original emdr was submitted to the non-production environment. This report is to submit to the production environment. This emdr contains the initial submission, fu#1 and fu#2.
 
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Brand NameACUSON S3000 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 Key7881100
MDR Text Key283503022
Report Number3009498591-2016-00385
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 company representative,user f
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUSON S3000
Device Catalogue Number10441730
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Is This a Reprocessed and Reused Single-Use Device? No

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