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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 6800
Device Problems Device Inoperable (1663); Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2014
Event Type  malfunction  
Event Description
The customer reported that the system failed to boot to a usable state and exhibited a non-recoverable loss of functionality.No pt serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service rep performed an onsite investigation.The cpu was evaluated and identified as requiring replacement.No conclusion can be drawn as conclusion repair info is unavailable at this time and no add'l service info was provided.
 
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Brand Name
6800
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 Key3835515
MDR Text Key16600552
Report Number1720753-2014-02872
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeGM
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 04/01/2014
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 Number6800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2014
Initial Date FDA Received04/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2002
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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