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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS GMBH 7900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS GMBH 7900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 7900
Device Problem Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2014
Event Type  malfunction  
Event Description
The customer reported the fluoroscopic image was degraded effectively eliminating the ability to view a usable image.No patient death or serious injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an investigation.The reported issue could not be duplicated.Onsite investigation revealed that no cause could be determined.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
7900
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS GMBH
14 wilhelm-maisel-str.
wendelstein D-90 530
GM  D-90530
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS GMBH
14 wilhelm-maisel-str.
wendelstein D-90 530
GM   D-90530
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key3874553
MDR Text Key4461863
Report Number9680959-2014-00563
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2014
Initial Date FDA Received04/22/2014
Was Device Evaluated by Manufacturer? Yes
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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