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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS GMBH 7700; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS GMBH 7700; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 7700
Device Problems Image Resolution Poor (1306); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2013
Event Type  malfunction  
Event Description
The customer reported that a fluoroscopic image was unable to be viewed.No patient death or serious injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The interconnect cable was evaluated and replaced.The associated interconnect connection was also repaired during the service call.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
7700
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS GMBH
14 wilhelm-maisel-str.
D-90 530
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 Key3769065
MDR Text Key4435016
Report Number9680959-2013-02357
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeFR
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 12/31/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2013
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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