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Model Number 350-005-000 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, there was moisture found from each of the video laryngoscope's blades.There was no patient involvement.
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Manufacturer Narrative
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D10 concomitant product: 350-005-000, mcgrath mac 3 blade 350-005-000 50 ct (lot#22111506); 350-005-000, mcgrath mac 3 blade 350-005-000 50 ct (lot#22111506); 350-005-000, mcgrath mac 3 blade 350-005-000 50 ct (lot#22111506) 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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Manufacturer Narrative
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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 it 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 present on the blade prism.It was reported that there was moisture found from each of the video laryngoscope's blades.The reported issue was confirmed.The most likely cause was traced to a component failure.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.
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Search Alerts/Recalls
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