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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Unique identifier: (b)(4). 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.
=
device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that a patient stated she had severe pain in her chest following a breast mri. The patient's physician ordered a chest x-ray that indicated a rib fracture. The patient was able to complete the exam.
 
Manufacturer Narrative
The investigation by ge healthcare has been completed. Based on the available information, there is no apparent root cause of the patient injury. There is no evidence that the signa architect scanner or sentinelle breast coil contributed to the injury. The technologist showed good clinical care in preparation and imaging of the patient.
 
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Brand NameSIGNA ARCHITECT
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key7573623
MDR Text Key110229864
Report Number2183553-2018-00008
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
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 Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
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: 06/06/2018 Patient Sequence Number: 1
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