MOSAIQ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-21 for MOSAIQ manufactured by Elekta Inc.

Event Text Entries

[181170043] The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Patient Sequence No: 1, Text Type: N, H10


[181170044] The customer reported a field change prior to treatment delivery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2950347-2020-00007
MDR Report Key9738827
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-02-21
Date of Report2020-02-21
Date Mfgr Received2020-01-24
Date Added to Maude2020-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPMS
Manufacturer StreetLINAC HOUSE FLEMING WAY
Manufacturer CityCRAWLEY, WEST SUSSEX RH109RR
Manufacturer CountryUK
Manufacturer PostalRH10 9RR
Manufacturer G1ELEKTA INC
Manufacturer Street400 PERIMETER CENTER TERRACE SUITE 50
Manufacturer CityATLANTA, GA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMOSAIQ
Generic NameACCELERATOR, LINEAR, MEDICAL
Product CodeIYE
Date Received2020-02-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerELEKTA INC
Manufacturer Address100 MATHILDA PLACE 5TH FLOOR SUNNYVALE, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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