Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 6800
Device Problems Failure to Power Up (1476); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2014
Event Type  malfunction  
Event Description
The customer reported that the hv cable was cut.Further information was received that indicated that the monoblock x-ray tube system failed to power up/allow fluoroscopic exposures.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The hv (high voltage) cable was evaluated and identified as requiring replacement.No conclusion can be drawn as conclusive repair information is unavailable at this time and no additional service information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key3821072
MDR Text Key4401806
Report Number1720753-2014-03348
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeGR
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 04/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2014
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
Date Manufacturer Received03/31/2014
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
-
-