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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
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HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D Back to Search Results
Model Number SDM-SYS-6000-3D
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code Radiation Exposure, Unintended (3164)
Date of Event 08/08/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by the customer "can't clear the gen 25:11 error and after reboot, saw gen 25:8 error too" which resulted in the need for an additional exposure to complete the exam.A field service engineer (fse) was dispatched which confirmed x-ray tube large filament is open.The fse replaced x-ray tube and performed all necessary calibrations.System passed all tests and meets all manufacturer's specifications.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
Common Device Name
MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key6849850
Report Number1220984-2017-00022
Device Sequence Number1430289
Product Code OTE
UDI-Device Identifier15420045505629
UDI-Public(01)15420045505629
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P080003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date (Section B) 08/08/2017
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? Yes
Operator of Device Radiologic Technologist
Device Model NumberSDM-SYS-6000-3D
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/08/2017
Initial Report FDA Received Date09/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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