Catalog Number C-VH-3010 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported post use for a coronary artery bypass procedure that t.W.Power supply generator is not reliable and does not work (no power).
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Manufacturer Narrative
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(b)(4).This is a reusable oem device; therefore, a serial/lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
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Event Description
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The hospital reported post use for a coronary artery bypass procedure that t.W.Power supply generator is not reliable and does not work (no power).There was no patient involvement.
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Search Alerts/Recalls
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