|
Model Number 350-013-000 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Manufacturer Narrative
|
D10: concomitant product: 350-013-000, mcgrath mac 4 blade 350-013-000 50 ct, (lot #22111102).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
|
According to the reporter, during use, the videolaryngoscope had a moisture when used.There was no reported patient outcome.
|
|
Manufacturer Narrative
|
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the blade had no physical damage.The blade was connected to a test device and was powered on.The display functioned properly, no issue was observed with the blade fit or glare.The device went through and failed anti-fog testing, with moisture generation on the blade prism.It was reported that the videolaryngoscope had a moisture when used.The reported issue was not confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
|
|
Search Alerts/Recalls
|
|
|