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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL
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ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Computer Software Problem (1112)
Patient Problem Radiation Overdose (1510)
Event Date 10/12/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.
 
Event Description
A third party supplier to a customer reported that the wedge fields were treated as open fields.Based on the available information mistreatment to a patient could potentially result in serious clinical outcome.
 
Manufacturer Narrative
Patient information updated.Updated: the investigation found if there are no wedge ids included in the dicom rt plan sent from the tps the field in mosaiq will be created with no wedge.Mosaiq is dependent on the presence of the wedge id to assign a wedge to a beam at the time of plan promotion, regardless of the presence of other wedge indicators (e.G.Number of wedges or wedge position).No warnings are presented if wedge ids are not present.If not discovered, it is possible that fields planned with wedges can be delivered without the wedge.Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.The root cause was that the wedge label was not defined in dicom plan, therefore mosaiq does not import wedge information at all.A recall has been released as the corrective action for the defect identified in mosaiq.Fca-ims-0027 was notified to the authorities on 11 december 2018.An ifsn 371-01-msq-013 was released to all affected customer sites on 13 december 2018.Three patches have been released for implementation in the field as follows: ifsm 371-02-msq-013 released date 6th february 2019 - mosaiq version 2.64.278 (sp11).Ifsm 371-02-msq-014 released date 6th february 2019 - mosaiq version 2.70.89.Ifsm 371-02-msq-015 released date 15th february 2019 - mosaiq version 2.65.249 (sp2).A further patch will be released for mosaiq versions lower than 2.64 which is estimated june 2019.
 
Event Description
A third party supplier to a customer reported that the wedge fields were treated as open fields.Based on the available information mistreatment to a patient could potentially result in serious clinical outcome.Elekta physics assessed that the overdose to the patient was 12% per fraction and 12% over the course of the treatment.
 
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Brand Name
MOSAIQ
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA INC
100 mathilda place
5th floor
sunnyvale CA 94086
MDR Report Key8093863
MDR Text Key128037638
Report Number2950347-2018-00037
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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