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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INC MONACO; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
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ELEKTA INC MONACO; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT Back to Search Results
Medical Device Problem Code Computer Software Problem (1112)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
 
Event or Problem Description
The customer reported that monaco will display the wrong mu or dose value on prescription ui for a 3d plan.Based on the available information there has been no mistreatment.
 
Additional 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 and will be fixed in a later version.
 
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Brand Name
MONACO
Common Device Name
SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
Manufacturer (Section D)
ELEKTA INC
13723 riverport drive
suite 100
maryland heights MO 63043
MDR Report Key7008658
Report Number1937649-2017-00006
Device Sequence Number489103
Product Code MUJ
UDI-Device Identifier00858164002169
UDI-Public(01)00858164002169(10)5.11.02
Combination Product (Y/N)N
Initial Reporter CountrySI
PMA/510(K) Number
K151233
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physicist
Type of Report Initial,Followup
Report Date (Section B) 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/10/2017
Supplement Date Received by Manufacturer10/10/2017
Initial Report FDA Received Date11/08/2017
Supplement Report FDA Received Date11/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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