MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number SEL-00001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

It was reported that they were getting an error message, which lost the images.This caused the patient to have the exposure repeated.It was determined that the generator needed to be replaced; once this was done, the unit is working as intended.

• 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 Key: 7155128
• MDR Text Key: 96061121
• Report Number: 1220984-2017-00290
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO10025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: SEL-00001
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1