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Model Number 0600-0771 |
Device Problems
Erratic or Intermittent Display (1182); Poor Quality Image (1408); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
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Event Description
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A customer reported that during a patient procedure, using a glidescope core video cable, the cable lost signal and had poor signal quality.No delay in the procedure, use of a backup device, or harm to the patient was reported.
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Manufacturer Narrative
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Upon verathon following up with the distributor regarding the return status of the glidescope core video cable, the distributor reported that the facility no longer was going to return the video cable but instead decided to purchase a new video cable.Since the device was not returned to verathon for evaluation, the cause could not be determined.The lot number of the video cable was not provided, therefore review for complaint history and the device history record of the video cable was unable to be performed.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Trending analysis for the glidescope core video cables does not identify any trends exceeding acceptable limits.Corrective action is not required at this time.Verathon will continue to monitor for trends.
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Search Alerts/Recalls
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