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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SIEMENS AG / SIEMENS HEALTHCARE GMBH MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Device Unsafe to Use in Environment (2918)
Patient Problem Injury (2348)
Event Date 08/08/2019
Event Type  No Answer Provided  
Event Description
Metal stool brought into mri suite and attached to magnet. Mri tech finger injured. No injury to pt.
 
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Brand NameMRI SCANNER
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG / SIEMENS HEALTHCARE GMBH
MDR Report Key8888857
MDR Text Key154456391
Report NumberMW5088982
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 08/12/2019 Patient Sequence Number: 1
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