Model Number VASOVIEW 6 PRO |
Device Problems
Improper Flow or Infusion (2954); No Flow (2991)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 an endoscopic vein harvesting procedure using vasoview 6 pro, customer reported issue with insufflation when using the btt.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Updated sections: g4,g7,h2,h6,h10.Internal complaint number: (b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using vasoview 6 pro, customer reported issue with insufflation when using the btt.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using vasoview 6 pro, customer reported issue with insufflation when using the btt.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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D4 correction: udi number changed to (b)(4).H6 correction: device codes changed to improper flow or infusion.H8 correction: usage of device changed to initial use.Internal complaint number: (b)(4).
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Search Alerts/Recalls
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