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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC GE FLUORO; X-RAY
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GENERAL ELECTRIC GE FLUORO; X-RAY Back to Search Results
Device Problems Intermittent Continuity (1121); Unintended Collision (1429); Device Inoperable (1663); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2015
Event Type  malfunction  
Event Description
The x-ray process suddenly stopped and the monitor read "collision".The radiology technician tried to fix the problem but was not successful.The radiological engineer tried to fix the problem but the screen still indicated a "collision".The team substituted with different portable equipment and finished the case.There was a 15 minute delay in the case.This is a recurrent issue.Per our radiological engineer, "the detector cover damage prevented the cover from fitting properly and was leaning against the control buttons and possibly causing intermittent collision errors which are generally resettable, however, the lift error was a hard error which puts the system down and requires user intervention.I replaced the cpu board in the positioner cabinet and performed calibration of the positioner.I cannot say with certainty that the cpu board failure was caused by the high temperature but it is the most likely reason for the system failure.".
 
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Brand Name
GE FLUORO
Type of Device
X-RAY
Manufacturer (Section D)
GENERAL ELECTRIC
9900 w. innovation dr.
wawatosa WI 53226
MDR Report Key4945756
MDR Text Key6635321
Report Number4945756
Device Sequence Number1
Product Code JAA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/24/2015
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 Other
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2015
Event Location Other
Date Report to Manufacturer07/28/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2015
Patient Sequence Number1
Patient Age69 YR
Patient Weight92
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