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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 Consequences Or Impact To Patient (2199)
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 the wrong mu was calculated for segment fields.Based on the available information there have been no actual mistreatment.
 
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and elekta were unable to reproduce the reported issue.
 
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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 Key7159533
Report Number1937649-2018-00001
Device Sequence Number1978931
Product Code MUJ
UDI-Device Identifier00858164002169
UDI-Public00858164002169
Combination Product (Y/N)N
Initial Reporter CountryEZ
PMA/510(K) Number
K151233
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,literature,other,user
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/20/2018
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? No
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/06/2017
Supplement Date Received by Manufacturer12/06/2017
Initial Report FDA Received Date01/03/2018
Supplement Report FDA Received Date02/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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