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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SIEMENS SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS HEALTHCARE GMBH SIEMENS SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Device Problems No Display/Image (1183); Data Problem (3196)
Patient Problem Insufficient Information (4580)
Event Date 12/23/2020
Event Type  malfunction  
Event Description
Pt was brought to scanner for ct stroke protocol scan.Perfusion scan was done but would not reconstruct.Siemens was called for tech support and was not able to resolve the issue.Exam was protected at scanner and siemens will send engineer out to download the raw data to attempt to process perfusion study offsite.Manufacturer response for siemens definition flash ct, siemens (per site reporter): siemens service engineer came and data was sent to siemens headquarters for analysis and processing.Siemens representatives stated that they are looking into this issue.The stated their belief that the source of the problem is embedded in the new scanner software, (b)(4).
 
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Brand Name
SIEMENS SOMATOM DEFINITION FLASH
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key11222517
MDR Text Key228428446
Report Number11222517
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2021
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27375 DA
Patient Weight62
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