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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SKYRA FIT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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SIEMENS HEALTHCARE GMBH MAGNETOM SKYRA FIT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 10849580
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 09/10/2019
Event Type  malfunction  
Event Description
Equipment ceased to acquire pictures during exam.The software version for our mri is ve 11c.Patient was scheduled for mri breast biopsy.Patient was thoroughly screened and consented for the procedure.Iv was started per routine protocol for contrast administration.Patient was positioned for the procedure.However, the mri machine failed to scan and obtain any images.Due to the machine failure, the procedure was aborted.Dr.Explained the situation to the patient and she was very understanding.Patient will be rescheduled as soon as the issue is resolved.
 
Event Description
Equipment ceased to acquire pictures during exam.The software version for our mri is ve 11c.Patient was scheduled for mri breast biopsy.Patient was thoroughly screened and consented for the procedure.Iv was started per routine protocol for contrast administration.Patient was positioned for the procedure.However, the mri machine failed to scan and obtain any images.Due to the machine failure, the procedure was aborted.Dr.Explained the situation to the patient and she was very understanding.Patient will be rescheduled as soon as the issue is resolved.
 
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Brand Name
MAGNETOM SKYRA FIT
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key9383176
MDR Text Key168287324
Report Number9383176
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10849580
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/15/2019
Device Age2 YR
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age17885 DA
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