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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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HOLOGIC, INC. SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM Back to Search Results
Model Number SEL=00030
Device Problem Device Issue (2379)
Patient Problem Not Applicable (3189)
Event Date 06/07/2016
Event Type  malfunction  
Manufacturer Narrative
The compression motor brake was slipping.The dealer field engineer replaced this part.
 
Event Description
After an exposure the compression paddle was released automatically, the patient stepped back out of compression and the compression paddle came back down on its own.The compression paddle won't drive up or down unless they are doing it manually.No one was hurt.
 
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Brand Name
SELENIA MAMMOGRAPHY SYSTEM
Type of Device
FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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 Key5758435
MDR Text Key48502955
Report Number1220894-2016-00020
Device Sequence Number1
Product Code MUE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PO10025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Health Professional
Remedial Action Repair
Type of Report Initial
Report Date 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSEL=00030
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
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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