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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 Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
 
Event Description
The customer reported a cma to site setup data mismatch.
 
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.It was ascertained that in the localisation trend review, it is possible to end up with two different "current" shift values for the same site.If the user were to randomly pick the incorrect shift, there could be a larger than accounted for discrepancy between the planned and delivered dose.This could be associated with a non-negligible degradation of plan quality.If the error was not detected it could result in non-serious injury.For the problem to occur, the localisation trend review (ltr) window would have to be opened concurrently for the same patient by two separate users.In addition the users would have to perform localisation edits for the same prescription.Ltr is not connected to cma (couch move assist) and therefore would not be used to alter current treatment, but could influence upcoming treatments.However, the patient would be imaged before any subsequent treatments and any discrepancies would be detected and investigated.Also, only one "current" shift value should be returned.When two "current" values are returned, this would prompt investigation by the user.The probability of this occurring would be implausible.No patients were mistreated.
 
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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 Key9502410
MDR Text Key188493265
Report Number2950347-2019-00026
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 01/28/2020
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
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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