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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 8800; FLUOROSCOPIC X-RAY

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GE OEC MEDICAL SYSTEMS 8800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 8800
Device Problem Failure to Power Up (1476)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 06/01/2015
Event Type  malfunction  
Event Description
The customer reported the system did not start (no boot).There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The batteries were replaced during the service call.The system was tested and found to be working and put back into service.
 
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Brand Name
8800
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
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 Key4938395
MDR Text Key6256696
Report Number1720753-2015-02937
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
NA
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 07/22/2015
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 Health Professional
Device Model Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2015
Initial Date FDA Received07/22/2015
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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