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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH - MR MAGNETOM AVANTO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 07391167
Device Problem Electromagnetic Compatibility Problem (2927)
Patient Problem Burn(s) (1757)
Event Date 02/21/2022
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 avanto system. It was reported that a patient suffered a burn and area of necrosis when using ecg electrodes. The injuries occurred in the area of the ecg electrodes used (covidien kendall 630 foam electrodes conductive adhesive hydrogel, radiolucent, lot number: 000652x). The patient was evaluated by a dermatologist for curative care and released. We are unaware of any further impact to the state of health of the patient involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameMAGNETOM AVANTO
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, germany 91052
GM 91052
Manufacturer Contact
meredith adams
40 liberty blvd.
malvern, PA 19355
4843231631
MDR Report Key13692972
MDR Text Key291240618
Report Number3002808157-2022-17748
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K123938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number07391167
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
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