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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9600
Device Problems Failure to Power Up (1476); Connection Problem (2900); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2014
Event Type  malfunction  
Event Description
The customer reported there was a false contacts on the interconnect cable and prevented the system from starting up.This resulted in a loss of imaging functionality.There is no report of death or serious injury associated with the complaint.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The interconnect cable needs to be replaced.The reported issue is currently under investigation.
 
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Brand Name
9600
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 Key4189576
MDR Text Key5098761
Report Number1720753-2014-08709
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeFR
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 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2014
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
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