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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL
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IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 05/29/2015
Event Type  No Answer Provided  
Event Description
It was reported that the user created an imrt plan with 25 fractions @ 200 cgy and a total dose of 5000 cgy and 7 treatment fields (1 - 7).After two fractions, user decided to change the fields and created 7 new fields.The user then edited the remaining sessions in the treatment calendar to schedule the new fields; removed the remaining sessions and created the remaining sessions again.Usually the system would only add the remaining 23 sessions when the user is selecting the same prescription for the calendar; however, 25 fractions were inserted again, which the user did not recognized.The full session was able to be delivered and there was no dose override message even though the total dose was reached.User did not recognize the problem until the next session where the override message displayed.Based on the available information, mistreatment occurred; however, did not result in serious injury.The user compensates the extra fraction treated by reducing the boost plan of 5 fractions @ 200 cgy to 4 fractions.
 
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The final investigation result is provided in the attachment.
 
Event Description
It was reported that the user created an imrt plan with 25 fractions @ 200 cgy and a total dose of 5000 cgy and 7 treatment fields (1 - 7).After two fractions, user decided to change the fields and created 7 new fields.The user then edited the remaining sessions in the treatment calendar to schedule the new fields; removed the remaining sessions and created the remaining sessions again.Usually the system would only add the remaining 23 sessions when the user is selecting the same prescription for the calendar; however, 25 fractions were inserted again, which the user did not recognized.The full session was able to be delivered and there was no dose override message even though the total dose was reached.User did not recognize the problem until the next session where the override message displayed.Based on the available information, mistreatment occurred; however, did not result in serious injury.The user compensates the extra fraction treated by reducing the boost plan of 5 fractions @ 200 cgy to 4 fractions.
 
Manufacturer Narrative
The "final assessment results" document submitted in follow-up #1 on 16th dec 2015 contained missing information about relevant user permissions.
 
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Brand Name
MOSAIQ
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
IMPAC MEDICAL SYSTEMS, INC.
100 mathilda place, 5th floor
sunnyvale CA 94086
Manufacturer (Section G)
IMPAC MEDICAL SYSTEMS, INC.
100 mathilda place, 5th floor
sunnyvale CA 94086
Manufacturer Contact
linac house
fleming way
crawley, west sussex RH10 -9RR
MDR Report Key4889812
MDR Text Key6829915
Report Number2950347-2015-00022
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative,company represent
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 12/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2015
Was Device Evaluated by Manufacturer? Yes
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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