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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 8800
Device Problems Device Inoperable (1663); Connection Problem (2900); Operating System Becomes Nonfunctional (2996)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2015
Event Type  malfunction  
Event Description
The customer reported that the system exhibited an error, failed to boot to a usable state and exhibited a non-recoverable loss of functionality.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The interconnect cable was evaluated and replaced.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
8800
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
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 Key4733295
MDR Text Key5737569
Report Number1720753-2015-01817
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeFR
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 04/24/2015
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 Health Professional
Device Model Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2015
Initial Date FDA Received04/24/2015
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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