Product analysis #(b)(4):2024-04-25 02:43:55 cdt webmremotews sfdcmnav product analysis task update: - workordername : (b)(4) analysis summary text : action/resolution: foot switch was disable/after change a new one the system come back normal cable grade: a demo/eval unit: false imaging modalities failure: 2d imaging modalities p/f: fail imaging summary of failure(s): foot switch was disable/after change a new one the system come back normal inspection and operational tests p/f: pass is imaging failure resolved?: yes mechanical inspection p/f: pass record type: o1 system checkout (closed) status: completed does the system perform as intended?: no visually inspected parts prior to instal: pass were hardware parts replaced?: yes less than 0.44: img src="/servlet/servlet.Filedownload?file=0156u000000auhq" alt="yes" style="height:16px; width:48px;" border="0"/> shoulder type: type 2.Section d information references the main component of the system.Other relevant device(s) are: product id: b i71000080.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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