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

Model Number SDM-00001-2D

Device Problems Collapse (1099); Shielding Failure (1568)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The x-ray shield is made of tempered glass (safety glass).The tempering is to assure that if the glass does fragment it fragments into smaller irregular pieces instead of shards.

Event Description

It was reported that the aws operator x-ray shield fragmented.There was no one in the room at the time of the event.There were no injuries reported.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAHPY SYSTEMS
• 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: 6337627
• MDR Text Key: 67660042
• Report Number: 1220984-2017-00005
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: PO10025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SDM-00001-2D
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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