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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 Problem Computer Software Problem (1112)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 04/04/2020
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 that mosaiq crashed 3 times when recording fractionation.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq re-started before the patient's plan was sent to the machine for treatment.A few minutes before mosaiq re-started, the following messages were noted in the ndicom log: 'timed out waiting on network partner' and 'association negotiation failed'.The patient's treatment delivery and recording were not affected after the application re-started.There was no mistreatment to the patient and all the deliveries were correctly recorded in mosaiq.
 
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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
MDR Report Key10020939
MDR Text Key189746181
Report Number2950347-2020-00013
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00858164002091
UDI-Public00858164002091
Combination Product (y/n)N
PMA/PMN Number
K183034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMOSAIQ
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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