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Model Number C-VH-3010 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2023 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply generator was not working.(not delivering energy) everything was working normal when the hemopro suddenly stopped working.It was a sudden stop and not a gradual decrease in energy.They performed a series of troubleshooting and diagnosing scenarios by changing adapters and cords etc, and determined the power supply was the issue by hooking up a different power supply and it worked.Short delay while trouble shooting the issue.No patient harm.
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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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N/a.
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Manufacturer Narrative
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Tw id# (b)(4).Updated section: b4, d10, g4, g7, h2, h3 h6, h10.The reported device is an oem device.The certificate of conformance was reviewed for the serial # h21070003g.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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