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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 8800
Device Problems No Display/Image (1183); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2014
Event Type  malfunction  
Event Description
The fse reported that the collimator iris wouldn't open.This resulted in a loss of imaging functionality.There is no report of injury or death associated with this event.
 
Manufacturer Narrative
A ge service rep performed an onsite investigation.The c-arm cable was evaluated and replaced.The sys was tested and found to be working as intended and returned to service.
 
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Brand Name
8800
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 Key3896805
MDR Text Key17278903
Report Number1720753-2014-04312
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeFI
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 05/19/2014
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 Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2014
Initial Date FDA Received05/19/2014
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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