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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9900; FLUROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS 9900; FLUROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2015
Event Type  malfunction  
Event Description
The customer reported the system continued to beep after the x-ray button was released.The fe clarified that the system lost communication and locked up, but no radiation was being produced.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The connectors were reseated and the power supply was adjusted during the service call.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
9900
Type of Device
FLUROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4535990
MDR Text Key16187746
Report Number1720753-2015-00794
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 02/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/05/2015
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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