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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS SKYRA 3T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS SKYRA 3T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number SKYRA
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Burn, Thermal (2530)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
Patient reported burn to inner thigh and face post mri. Siemens performed tests on mri equipment - on (b)(6) 2020 and (b)(6) 20. All tests were within normal limits. Fda safety report id# (b)(4).
 
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Brand NameSIEMENS SKYRA 3T
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
MDR Report Key11071916
MDR Text Key223749836
Report NumberMW5098519
Device Sequence Number1
Product Code LNH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSKYRA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/23/2020 Patient Sequence Number: 1
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