Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLOUROSCOPIC X-RAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE OEC MEDICAL SYSTEMS (SLC) 9900; FLOUROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2015
Event Type  malfunction  
Event Description
The customer reported that the system failed to boot 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 onsite investigation.The rtos (real time operating system) cpu assembly was evaluated and replaced.The system was tested and found to be working as intended and returned to service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
9900
Type of Device
FLOUROSCOPIC 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 Key4945218
MDR Text Key18995505
Report Number1720753-2015-03013
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 07/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Device Lot NumberEC-0330
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-