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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9600
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/12/2014
Event Type  malfunction  
Event Description
The customer reported that there was an 'saturation fault' error message displayed.This error is likely to result in an immediate loss of system functionality and an un-commanded shut down.There is no report of a pt injury or death associated with this event.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The hv cable connections to the x-ray tube were evaluated, relubricated and reseated.The system was tested and found to be working as intended and put back into use.
 
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Brand Name
9600
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key3902116
MDR Text Key4676601
Report Number1720753-2014-01775
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2014
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 Number9600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2014
Initial Date FDA Received02/24/2014
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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