Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and investigations.No adverse trend was identified for the customers issue and no other customers have reported dust.Labeling was reviewed and found to be adequate.The dust components were identified as aluminum and zinc as the primary dust constituents from the analysis.The customer indicated that the ventilation system was evaluated and was functioning properly, all vents were cleaned and inspected.Safety shields and covers are present over the entire system and are to remain in place unless specifically instructed to remove them to perform certain procedures.A study measured concentrations of different components of the track dust, all were found to be below permitted limits as established by the (b)(4).Additional measures besides the covers and shields cited above are in place to reduce exposure to dust generated by the system.Preventive maintenance (pm) is performed every 6 months which includes utilization of a vacuum cleaner with a 0.3 micron hepa filter to remove dust.Steel strips were installed on the system and testing showed that the application of the steel strips mitigates the creation of dust.Based on all available information and abbott diagnostics' complaint investigation, the device performed as intended and no product deficiency was identified.
|
(b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
|