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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ONCOLOGY INFORMATION SYSTEM
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IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ONCOLOGY INFORMATION SYSTEM Back to Search Results
Model Number 2.41.01J0
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
We use elekta's mosaiq radiation oncology record and verify system version 2.41.01j0 in our radiation oncology clinic.We recently found it necessary to resend reference ct and structure set information for an igrt patient, with the intent to apply the new reference data to future imaging and treatment sessions.To our great dismay, we found (and an elekta representative confirmed) that mosaiq also applies the new reference data retroactively to previous approved cbct images, showing the same shifts were made based upon different reference data.This effectively changes the record of what was done and what was approved, making it look like different (and possibly completely inappropriate) localization decisions were made.Since this happens retroactively it may not be a patient safety concern, but it could be a huge liability issue for radiation oncologists and radiotherapy clinics.It is difficult to believe the fda would grant approval to a system that allows retroactive changes to approved records.
 
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Brand Name
MOSAIQ
Type of Device
ONCOLOGY INFORMATION SYSTEM
Manufacturer (Section D)
IMPAC MEDICAL SYSTEMS, INC.
sunnyvale
MDR Report Key4466408
MDR Text Key5182381
Report NumberMW5040464
Device Sequence Number1
Product Code IYE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2.41.01J0
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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