Model Number BI70002000 |
Device Problems
Poor Quality Image (1408); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/15/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Section d references the main component of the system.Other medical products in use during the event include: product id: bi71000138, serial/lot: unknown. h3, h6) no parts have returned to the manufacturer for analysis.Codes b17, c20, and d15 are applicable.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the site accidentally drove the system into the wall, damaging the sidewall cover.It was reported that the image quality had diminished due to the impact.The scans were good up until the crash.There was no patient involvement.
|
|
Manufacturer Narrative
|
H2-3) a manufacturer representative (rep) went to the site to test the imaging system.The sidewall cover was replaced and the system performed as intended.Codes: b01, c07, d02 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|