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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM AVANTO; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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SIEMENS HEALTHCARE GMBH MAGNETOM AVANTO; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Inflammation (2443)
Event Date 12/16/2017
Event Type  malfunction  
Event Description
Post-partum patient with right leg edema sustained small bilateral blisters on the insides of her thighs just above the knees.She was advised by the technologist not to cross her legs, and her legs were positioned apart.Patient said she felt something during the scan, and when she informed the tech, he stopped the machine.There were two welts on the insides of her thighs.The patient wanted to proceed with the scan.After the scan was complete, blisters appeared in the area of the welts.The patient was wearing a dermatherapy gown and a polyester robe.Nothing was touching the area where the blisters arose.
 
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Brand Name
MAGNETOM AVANTO
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key7236814
MDR Text Key98861788
Report Number7236814
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/02/2018,01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/02/2018
Event Location Hospital
Date Report to Manufacturer01/02/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
Patient Weight80
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