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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation.The cine hard disk drive was evaluated and identified as requiring replacement.No conclusion can be drawn as further system analysis, testing or repair information is unavailable at this time and no additional service information was provided.
 
Event Description
It was reported that the system experienced a loss of cine functionality.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
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 
MDR Report Key6216071
MDR Text Key63661237
Report Number1720753-2016-03542
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeFR
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 12/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2011
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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