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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL
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ELEKTA SOLUTIONS AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 03/27/2024
Event Type  malfunction  
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.Please note this case refers to patient 1.There are two patients involved for this incident (see clm (b)(6) for the second patient).
 
Event Description
The customer reported an error in the machine interface.
 
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Brand Name
MOSAIQ
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA SOLUTIONS AB
hagaplan 4
stockholm, SE-11 3 68
SW  SE-113 68
Manufacturer (Section G)
ELEKTA SOLUTIONS AB
400 perimeter center terrace
suite 50
atlanta GA 30346
Manufacturer Contact
cornerstone
london road
crawley, west sussex RH10 -9BL
MDR Report Key19179014
MDR Text Key341008171
Report Number3015232217-2024-00014
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00858164002367
UDI-Public(01)00858164002367(10)2.83.053
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K183034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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