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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM, 2D
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HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM, 2D Back to Search Results
Model Number SDM-00001-2D
Device Problem Unintended Movement (3026)
Patient Problem Not Applicable (3189)
Event Date 04/25/2018
Event Type  malfunction  
Event Description
It was reported that the c-arm rotated uncommanded, past the normal detents.No injury was reported.It was determined that the circuit board needed to have the detents activated.Once this was completed the system was working as intended.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D
Type of Device
FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM, 2D
Manufacturer (Section D)
HOLOGIC, INC.
36 & 37 apple ridge road
danbury CT 06810
Manufacturer Contact
debra rosenberg
36 & 37 apple ridge road
danbury, CT 06810
2032074512
MDR Report Key7540004
MDR Text Key109104555
Report Number1220984-2018-00100
Device Sequence Number1
Product Code MUE
UDI-Device Identifier15420045505582
UDI-Public15420045505582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberSDM-00001-2D
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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