Catalog Number C-XP-5000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 a coronary artery bypass procedure, acrobat-i positioner would not hold position after tightening.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint number: (b)(4).Autonumber # (b)(4).
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Event Description
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The hospital reported that during a coronary artery bypass procedure, acrobat-i positioner would not hold position after tightening.The hospital did not report any patient effects.
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Search Alerts/Recalls
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