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Model Number 0800-0543 |
Device Problems
Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer declined the option to have their glidescope spectrum smart cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined; however, it is likely that the reported damage to the cable may have caused or contributed to the image issue.The glidescope video laryngoscopes 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." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Review of complaint history for the reported serial number (b)(6) did not identify any previous complaints reported to verathon.Trending analysis for the glidescope spectrum smart cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.
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Event Description
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A customer reported that during a patient procedure, using a glidescope spectrum smart cable, the doctor was unable to view the patient's airway and had to move the cable around to get it to work.The customer reported damage to the hdmi portion of the smart cable.No delay in the procedure, use of a backup device, or harm to the patient was reported.
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Search Alerts/Recalls
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