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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problem Loss of Data (2903)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation.The system software and configuration files were evaluated and reloaded.No additional service information was provided.
 
Event Description
The customer reported that the system failed to properly save patient image data.No patient serious injury or death was reported related to this event.
 
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Brand Name
9900
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 84116
MDR Report Key5654990
MDR Text Key45194032
Report Number1720753-2016-01233
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Device Lot NumberES-7268-CMH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2012
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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