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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9900 C-ARM 9" STD; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS 9900 C-ARM 9" STD; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problem Device Difficult to Maintain (3134)
Patient Problem Laceration(s) (1946)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
During servicing activities to replace the positioning brakes on a 9900 elite mobile c-arm, while one field engineer (fe) had his head down inspecting the brake assembly, another fe released the brake, causing part of the system to swing at a high rate of speed and hit the face of the fe who was inspecting the brake assembly.The impact caused a laceration which required stitches to resolve.The fe has since returned to work.Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be submitted when the investigation has been completed, if additional information is identified.
 
Event Description
During servicing activities to replace the positioning brakes on a 9900 elite mobile c-arm, while one field engineer (fe) had his head down inspecting the brake assembly, another fe released the brake, causing part of the system to swing at a high rate of speed and hit the face of the fe who was inspecting the brake assembly.The impact caused a laceration which required stitches to resolve.The fe has since returned to work.
 
Manufacturer Narrative
Ge healthcareâs root cause investigation related to this event is now complete.The investigation concluded that the field service engineer failed to follow the proper service instructions in the service manual and was not properly trained.This event is being corrected by the field engineer receiving additional training and there was not malfunction of the device related to this event.
 
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Brand Name
9900 C-ARM 9" STD
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS
384 wright brothers drive
salt lake city, UT 84116
MDR Report Key11667499
MDR Text Key255914834
Report Number1720753-2021-00002
Device Sequence Number1
Product Code OXO
Combination Product (y/n)N
PMA/PMN Number
K120613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number9900
Device Lot NumberE9-1721
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/15/2021
Initial Date FDA Received04/14/2021
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
Patient Weight95
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