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

Model Number SDM-05000-2AC

Device Problems Fire (1245); Device Emits Odor (1425); Smoking (1585); Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

As of today the investigation and part evaluation regarding this issue is still in-process.A follow-up will be filed as needed.

Event Description

It was reported that while positioning a patient for an exposure the technologist noticed the system had "gone quiet" and was displaying a message to call service, no error code was noted.The technologist noted a burning smell and smoke, the patient was removed from the room and the system was turned off.No injury was reported.The exam was completed in another room and one image was repeated which resulted in the patient receiving additional radiation.

Manufacturer Narrative

The detector was received for evaluation on 7/2/2018 and the evaluation determined that a single blown capacitor caused a short burst of flame, nothing prolonged.The pcbs with flammability ratings extinguished as expected.Delrin material, when exposed to an open flame for a duration (approximately 2 seconds) can catch fire and slowly burn.Other components within the chamber were subject to a rudimentary "burn test" with nothing catching or remaining on fire.The gantry was received for evaluation on 10/22/2018.The power distribution drawer was removed and was verified to have all appropriate fuses installed, with no blown fuses observed during the review.This is an indication of no power surge coming in via the gantry.This occurrence is the first in the history of the detectors manufactured for any hologic selenia or selenia dimensions system.No corrective action is required.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: SELENIA DIMENSIONS 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: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 7650827
• MDR Text Key: 113000220
• Report Number: 1220984-2018-00107
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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
• Device Operator: Radiologic Technologist
• Device Model Number: SDM-05000-2AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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