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Model Number C-VH-3010 |
Device Problems
Crack (1135); 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 10/19/2023 |
Event Type
malfunction
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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 t.W.Power supply was not working, the housing is cracked.
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Manufacturer Narrative
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Trackwise # (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.A serial 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.H3 other text : device discarded.
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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 was not working, the housing is cracked and it would not turn on.There was no procedural delay.No harm to patient.
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Search Alerts/Recalls
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