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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 Problems Failure to Charge (1085); Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2014
Event Type  malfunction  
Event Description
The customer reported the charged failed and the system would not boot up.This resulted in a total loss of imaging functionality.There is no report of injury or death associated with this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The mainframe batteries and hard disk drive were evaluated and replaced.The system was tested and found to be working as intended and returned to service.
 
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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 (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4005787
MDR Text Key4710917
Report Number1720753-2014-06394
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 07/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2014
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
Date Manufacturer Received07/09/2014
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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