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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X300 PE ULTRASOUND SYSTEM ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X300 PE ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON X300 PE
Device Problem Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 12/19/2015
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 provide additional event information, correct the patient code and provide additional manufacturer narrative. Multiple attempts were made to obtain additional information and patient outcome but with no results. 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. During review of the service report, it was reported that the user smelled smoke and the system will not power up. 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.
 
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Brand NameACUSON X300 PE 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 Key6655385
MDR Text Key281428661
Report Number3009498591-2016-00417
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K121699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
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 Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUSON X300 PE
Device Catalogue Number10348531
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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