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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
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 investigation was completed by conducting a thorough evaluation of the product and the reported information.A defect was found internally and not reported by a customer.When the pregnancy and or implant status flags have been set to "no" the expiration dates are not considered.Therefore the patient could be pregnant and/or could have an implantable device and treatment will not be prevented as it should be.This issue will be resolved in a future release.
 
Event or Problem Description
During elekta internal investigations it was found that pregnancy and implant status do not have any rate range checking.
 
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Brand Name
MOSAIQ
Common Device Name
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA INC
100 mathilda place
5th floor
sunnyvale CA 94086
MDR Report Key8455035
Report Number2950347-2019-00003
Device Sequence Number16250562
Product Code IYE
UDI-Device Identifier00858164002220
UDI-Public00858164002220
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K183034
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/27/2019
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 Other
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2019
Initial Report FDA Received Date03/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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