Model Number C-VH-3010 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2023 |
Event Type
malfunction
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Event Description
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The hospital reported that t.W.Power supply s/n: (b)(6), used for endoscopic vein harvesting procedure power supply was not working and won't turn on.
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Manufacturer Narrative
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Tw id# (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 preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n: (b)(6) power supply was not working and won't turn on.There was no delay and no patient was involved.
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Manufacturer Narrative
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(b)(4).Corrected sections: h6--health effect ¿ clinical code corrected from "4580" to "4582".The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.H3 other text : device not returned.
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Search Alerts/Recalls
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