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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
Model Number MOSAIQ
Device Problems Computer Software Problem (1112); Application Network Problem (2879)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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
Elekta were informed that the customer reported an issue with treatment which is stopping without recording the session.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the reported information.Attempts were made to obtain additional information, however the customer no longer wishes to proceed with further investigation.From the reported information, it appears that the issues were resolved after changes were made to the site's network configuration.Therefore, mosaiq did not have any malfunction and is working as designed and intended.There was no patient mistreatment.
 
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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 Key10395431
MDR Text Key202528224
Report Number2950347-2020-00027
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00858164002091
UDI-Public00858164002091
Combination Product (y/n)N
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMOSAIQ
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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