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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH- MR MAGNETOM AERA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 10432914
Device Problem Excessive Heating (4030)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 11/21/2020
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 an adverse event occurred following examination on the magnetom aera system. It was reported that a male patient suffered second degree burns (approximately 15mm in diameter) to both inner thighs. The patient received medical treatment by the medical team. 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 AERA
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH- MR
henkestrasse 127
erlangen, germany 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH - MR
henkestrasse 127
erlangen 91052
GM 91052
Manufacturer Contact
marlynne galloway
40 liberty blvd.
65-1a
malvern, PA 19355
6104486471
MDR Report Key11038136
MDR Text Key222359136
Report Number3002808157-2020-58550
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K191050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10432914
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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