MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3DC

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Headache (1880)
Date of Event	01/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer states that the compression paddle is releasing to too quickly which is throwing the patients off balance and they fall.Our dealer field service engineer evaluated the unit and did not find any issues.The compression release time is normal the paddle upward motion was smooth.The technologists said the condition of the patients involved was the reason for the falls.We also had a clinical applications specialist talks to the site and was told the first patient was an elderly did not have her feet properly balanced, this was confirmed by the patient as well.The second patient was also elderly, it was unclear what caused the patient to fall.The applications specialists suggested that when doing elderly patients they change the compression paddle release mode to manual.Device evaluated by dealer.
Event or Problem Description
On (b)(6) 2016 one patient fell when being released from compression, the patient fell backward against the control panel and into the wall by the stored compression paddles.Afer the patient had fallen, she told the technician she wasn't feeling well that morning and took her blood pressure medicine.They evaluated the patient who had scrapped her elbow and had a headache.The took her blood pressure which was 150/90.The patient was sent to the er where they diagnosed a brain bleed, but couldn't say whether the fall caused it.(b)(6), the interim radiology manger didn't have any further details and the same for follow-up on the patient.There was another incident some time in (b)(6), (b)(6) did not know exactly when or many of the details.The patient was in compression and had a bigger stomach, with her face up against the face shield and due to her larger stomach they had to adjust her stomach to get her breast up onto the detector.When compression released, she fell back and the tech was able to get to her as she was falling and guided her to the floor.(b)(6) spoke to the patient who was unhurt and had no pain.She also said she had no new back pain.(b)(6) is not sure about any follow up at this time.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3DC
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 5664689
• Report Number: 1220894-2016-00006
• Device Sequence Number: 250216
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: PO8003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2016
• Initial Report FDA Received Date: 05/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention