Model Number 0570-0382 |
Device Problems
Erratic or Intermittent Display (1182); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2020 |
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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The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the cable connection was reported as "loose." the image would intermittently go in and out while in use.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
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Manufacturer Narrative
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A replacement glidescope video baton 2.0 large was provided to the customer and the video baton 2.0 large used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 large and confirmed that the image cut in and out during normal use.The verathon technical service representative noted that the hdmi connector showed signs of wear and tear.Since the customer had already received a replacement glidescope video baton 2.0 large, the returned device was scrapped.No corrective action is required at this time.Verathon will continue to monitor for trends.The glidescope operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged.
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Search Alerts/Recalls
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