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.Upon review of the device history for serial number (b)(4), it was determined that the device was manufactured on (b)(6) 2013 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).
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The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, there was an intermittent picture.A slight bubble in the cable where it connects to the monitor was noted.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
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