MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D

Model Number SDM-00001-2D

Device Problem Unintended Arm Motion (1033)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

One of the footswitches that move the c-arm vertically had stuck.Both footswitches were replaced.

Event Description

C-arm lowered with patient in compression.The technologist was in the process of positioning the patient when the c-arm started to move down.The technologist moved the patient back out of the way.No injury to the patient.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D
• Type of Device: 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: 5680807
• MDR Text Key: 47215085
• Report Number: 1220984-2016-00010
• Device Sequence Number: 1
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO80003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• 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?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1