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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-05000-3DC
Medical Device Problem Code Unintended System Motion (1430)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during positioning the c-arm continued to move until it was completely upside down.No injury reported.A field engineer was dispatched to the site and determined the c-arm rotation switch was too close to the c-arm enclosure surface.Rather than just adjusting the switch position the switch was replaced as a precaution.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 Key11903105
Report Number1220984-2021-00015
Device Sequence Number13783225
Product Code OTE
UDI-Device Identifier15420045505636
UDI-Public15420045505636
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P080003
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/28/2021
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-05000-3DC
Device Catalogue NumberSDM-05000-3DC
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date05/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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