Catalog Number C-VH-3010 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/06/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) 2015 02:39 pm (gmt-4:00) added by (b)(4): the device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, hemopro t.W.Power supply stopped working.A replacement device was used to complete the case.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).This is a reusable oem device; therefore, a lot history review is not applicable.The product is not returning.The hospital reported that the device is no longer under warranty.A lot number was not provided and the specific product serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.(b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, hemopro t.W.Power supply stopped working.A replacement device was used to complete the case.The hospital did not report any patient effects.
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Search Alerts/Recalls
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