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 29 jun 2015 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, when the cable was flexed, a wire near the top of the baton was shorting.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
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