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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 3.0T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC GE 3.0T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Use of Device Problem (1670); Device Unsafe to Use in Environment (2918); Device-Device Incompatibility (2919)
Patient Problems Bone Fracture(s) (1870); Skin Irritation (2076); Multiple Fractures (4519)
Event Date 10/18/2020
Event Type  Injury  
Manufacturer Narrative
Age: 25-30 years old. Weight: 50-55kg. Unique identifier: udi not required. There are no additional device identification numbers. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
 
Event Description
It was reported that a staff member brought a ferrous oxygen tank into the scan room that became attracted to the magnet. When moving toward the magnet, the tank struck a staff member on the right side of their mid section, scratching the palm of their hand and breaking two ribs, for which she was admitted to the hospital for treatment. The patient was not injured due to this issue. The ge field engineer ramped ramped down the magnet and removed the oxygen tank from the room.
 
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Brand NameGE 3.0T SIGNA HDX MR SYSTEM
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
youssef halas
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key10831928
MDR Text Key216113663
Report Number2183553-2020-00016
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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