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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Radiation Overdose (1510)
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative
Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
The user initiated and confirmed a scan 51 individual times; yielding a large dose to a patient.This large dose is an expected and foreseeable side effect of repeatedly initiating a scan.There was no device malfunction.The user was untrained.
 
Manufacturer Narrative
The cause of the incident is user error.The operator used the ¿one more¿ button to add additional slices to the original scan 51 times (52 total scans).Gehc engineering analysis of the system log files executing the scans in this way yields a total ct dose over 6gy.Cm.Additionally, the scan request files indicate that all scans were commanded by the user.There was no system malfunction.The dose check function default setting is on at install, but was disabled by this site immediately after the system was installed on 05 mar 2015.If the dose check function was used, an alert notification would have alerted the user to potential high dose being given.The dose check setup and usage is described in the operator manual chapter 5.
 
Event Description
The user initiated and confirmed a scan 51 individual times; yielding a large dose to a patient.This large dose is an expected and foreseeable side effect of repeatedly initiating a scan.There was no device malfunction.The user was untrained.
 
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Brand Name
OPTIMA 660
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
west area of building no.3
no.1 yongchang north road
beijing
CH 
Manufacturer Contact
susan strasser
3000 north grandview blvd
waukesha, WI 
MDR Report Key7405461
MDR Text Key104659970
Report Number9613445-2018-00001
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 06/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Other Device ID NumberUDI NOT REQUIRED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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