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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 04/17/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As of today, the investigation is still in process and a follow up will be filed as needed.
 
Event or Problem Description
It was reported that when attempting to rotate to the mlo position, the machine does not stop at the 45 degree angle.Instead the c-arm would continue to rotate unprompted.No injury reported.A field engineer was dispatched to the site.
 
Event or Problem Description
It was noted that the customer had rebooted the system which resolved the issue.The system was monitored and on follow up the issue had not returned.
 
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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 Key8587903
Report Number1220984-2019-00047
Device Sequence Number16560860
Product Code OTE
UDI-Device Identifier15420045505636
UDI-Public15420045505636
Combination Product (Y/N)N
Initial Reporter StateGA
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) 04/17/2019
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 04/17/2019
Supplement Date Received by Manufacturer05/13/2019
Initial Report FDA Received Date05/07/2019
Supplement Report FDA Received Date05/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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