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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 Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that lab results in the work list that the physician uses are not coming across as highlighted.There was no report of mistreatment based on the available information.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product.The issue was determined to be a defect in the product.This defect will be fixed in a later version.
 
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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
100 mathilda place, 5th floor
sunnyvale 94086
4088308023
MDR Report Key4489045
MDR Text Key5331138
Report Number2950347-2015-00002
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 02/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Other Device ID NumberVERSION 2.60.234
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2014
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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