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Catalog Number C-VH-3010 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/07/2018 |
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 that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was not working, light does not come on.Long out of warranty, no repair options or replacements were offered.No patient involvement.
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Manufacturer Narrative
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Updated sections: internal complaint number: (b)(4).Autonumber: (b)(4).This is a reusable oem device; therefore, a lot history review is not applicable.Based on the serial number provided, we were unable to find when the device was sold to the account.The certificate of conformance (c of c) was not available for review because, the reported serial number does not appear to be included in any of the batches received in maquet wayne.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was not working, light does not come on.Long out of warranty, no repair options or replacements were offered.No patient involvement.
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Search Alerts/Recalls
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