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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC. OEC 9900 ELITE; SYSTEM, X-RAY, FLUOROSCOPIC X-RAY SYSTEM, MOBILE
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GE OEC MEDICAL SYSTEMS, INC. OEC 9900 ELITE; SYSTEM, X-RAY, FLUOROSCOPIC X-RAY SYSTEM, MOBILE Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Failure to Power Up (1476); Computer Operating System Problem (2898); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2014
Event Type  malfunction  
Event Description
A work order was received from imaging staff that the c-arm won't power up.The device was troubleshooted and it was found that the isd (intelligent shutdown board) was bad and kept blowing fuses.The isd board was replaced and the c-arm worked fine for about two months.After that time, another call was received from the imaging tech again about the same problem and it was found out that the isd board was bad again.The board was replaced under warranty.The bad board was sent back to ge/oec for credit and evaluation.Before returning the unit back to service, we found the locking nut for the umbilical cord (high-voltage cable to the c-arm from workstation) connector assembly was loose.This might have been what's causing this isd board to short out and blow fuses.Ever since the connector has been fixed, we no longer received calls about this problem.Also it is very important to unplug from the outlet first before unplugging the high voltage cable from the c-arm to the workstation.
 
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Brand Name
OEC 9900 ELITE
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS, INC.
384 wright brothers dr.
salt lake city UT 84116
MDR Report Key4873979
MDR Text Key6062024
Report Number4873979
Device Sequence Number1
Product Code JAA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2015
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer06/29/2015
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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