MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
|
Back to Search Results |
|
Model Number BI70000028120 |
Device Problem
Application Program Problem (2880)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/05/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3, h6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000475, product id: bi71000734.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.
|
|
Event Description
|
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the site received an image frame rate below recommended level error. there was no patient involvement.
|
|
Manufacturer Narrative
|
H6) the system was serviced in the field and it was confirmed there were frame rate errors.The umbilical cable was checked and it was found that wiggling it causes a loss of communications.The umbilical cable was replaced and the system then performed as intended.Codes b01, c07, and d02 are applicable to this system checkout.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.
|
|
Manufacturer Narrative
|
H2: product bi71000734 was returned to the manufacturer and is not related to this event.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
|
|
|