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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 Image Reversal (1358)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2014
Event Type  malfunction  
Event Description
The customer stated that during a case the images became scrambled; they had to reboot the system to finish the case.There is no report of injury or death associated with the event described in this complaint.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The high voltage cable was replaced and the generator was calibrated during the service call.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
9900
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 Key3876811
MDR Text Key20266886
Report Number1720753-2014-04201
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 05/15/2014
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 Number9900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2014
Initial Date FDA Received05/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2009
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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