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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
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HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D Back to Search Results
Model Number SDM-SYS-9000-3D
Medical Device Problem Code Unintended System Motion (1430)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As of today the investigation is still in progress and a follow up will be filed as needed.
 
Event or Problem Description
It was reported that the c-arm rotates too far.No injury reported.A field engineer was dispatched to the site.
 
Event or Problem Description
It was determined that the c-arm transition board and rotary switch needed to be replaced.Once this was completed the system was working as intended.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
Common Device Name
MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key9278223
Report Number1220984-2019-00121
Device Sequence Number19504356
Product Code OTE
UDI-Device Identifier15420045505636
UDI-Public15420045505636
Combination Product (Y/N)N
Initial Reporter StateIA
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/18/2019
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 Health Professional
Device Model NumberSDM-SYS-9000-3D
Device Catalogue NumberSDM-SYS-9000-3D
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/18/2019
Supplement Date Received by Manufacturer12/02/2019
Initial Report FDA Received Date11/05/2019
Supplement Report FDA Received Date12/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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