Catalog Number C-VH-3010 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Please disregard previous lot history statement.This is a reusable eom device.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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).
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Event Description
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The hospital reported that t.W.Power supply broke.Serial number (b)(4) warranty expired december 17, 2015.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.Based on the serial number provided, the device was sold to the account on (b)(6) 2014 which places the approximate usage life at approximately 1 year and 4.5 months.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 that t.W.Power supply broke.Serial number (b)(4) warranty expired december 17, 2015.The hospital did not report any patient effects.
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Search Alerts/Recalls
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