[96842375]
The customer, (b)(6), reported the panel of their panther instrument 19" pcap glass monitor detached from the base of the touch screen monitor and fell to the floor. However, the glass panel did not break. The glass panel took the digitizer with it as it broke off from the ribbon cable and thus became unresponsive to touch input. The customer was able to use the keyboard to enter input without the touchscreen panel in place until the monitor was replaced. Hologic's risk assessment was completed on 21dec2017 after the monitor was returned for evaluation. It wasn't until the initial investigation was complete that hologic identified that this could cause injury and would be considered a reportable event. There are two associated risks that hologic assessed. The risk of incorrect results: per hologic's risk assessment, there is no impact to results as the monitor is used to display the graphical user interface and the instrument can continue to run without the touch panel. The severity associated with incorrect results is negligible since the instrument will continue to function as expected. The risk of operator injury: per hologic's risk assessment, the safety impact for possible medical intervention caused by the falling glass panel would have a serious severity rating. According to the supplier, the glass panel is made of shatter resistant glass and has smooth rounded edges, therefore, injury due to broken glass is unlikely. Although the glass panel is shatter resistant and did not break, a customer safety risk exists whereby the glass panel could cause injury due to the force of the impact striking a bystander as it falls from the base. The glass panel weight is approximately 0. 5 kilograms and at worst could cause reversible injury that might require professional medical intervention. There have been 2 instances of monitors becoming detached; however, no injury has occurred.
Patient Sequence No: 1, Text Type: D, B5