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 10/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Tw id# (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.H3 other text : not returned.
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Event Description
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Hospital reported t.W.Power supply s/n (b)(6) is not working.Not powering on.Used another vh-3010 hp generator to complete case.No delays reported.No patient effects.
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Manufacturer Narrative
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Trackwise#: (b)(4).The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.
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Event Description
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N/a.
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Search Alerts/Recalls
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