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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 2800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 2800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 2800
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2014
Event Type  malfunction  
Event Description
The customer reported the uroview 2800 foot extension accessory was difficult to remove from the end of the table.No patient death or serious injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The leg extension accessory release tabs were evaluated and repaired.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
2800
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 Key4203077
MDR Text Key5040894
Report Number1720753-2014-07999
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 09/18/2014
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 Number2800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2014
Initial Date FDA Received09/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2006
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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