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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM SKYRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SIEMENS HEALTHCARE GMBH - MR MAGNETOM SKYRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 10432915
Device Problem Excessive Heating (4030)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 12/17/2020
Event Type  Injury  
Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
 
Event Description
It was reported to siemens that a patient suffered a burn on the left shin (approximately 15 cm x 7 cm in diameter) following examination on the magnetom skyra. It was reported that the patient had undergone a wrist scan for surgery that was completed without incident and the patient was discharged. The patient returned from wrist surgery and reported that their leg was burned during the mr scan. No further information regarding the type of treatment was provided. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameMAGNETOM SKYRA
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH - MR
henkestrasse 127
erlangen, 91052
GM 91052
MDR Report Key11331695
MDR Text Key232053077
Report Number3002808157-2021-65066
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
PMA/PMN Number
K121434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10432915
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/16/2021 Patient Sequence Number: 1
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