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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA MOSAIQ; ACCELERATOR, LINEAR, MEDICAL
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CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Patient Data Problem (3197)
Patient Problem No Information (3190)
Event Type  No Answer Provided  
Event Description
It was reported that the physician was seeing strange image sets.One patient image showed an overlaid structure set of another patient's image.There was no mistreatment reported based on the available information.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue occurred intermittently and could not be replicated.Cause could not be determined.
 
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Brand Name
MOSAIQ
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA
impac medical systems,inc.
100 mathilda place, 5th floor
sunnyvale 94086
Manufacturer (Section G)
CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA
impac medical systems,inc.
100 mathilda place, 5th floor
sunnyvale 94086
Manufacturer Contact
christopher ivicevich
impac medical systems
100 mathilda place, 5th floor
sunnyvale 94086
4088308023
MDR Report Key4327241
MDR Text Key5133023
Report Number2950347-2014-00035
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123230
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Other Device ID NumberVERSION 2.60.257
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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