Catalog Number C-HS-3045 |
Device Problem
Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/27/2017 |
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 preparation for a coronary artery bypass procedure, hs iii proximal seal dropped inside of the delivery device.Another product was used to complete the procedure and no patient injury was reported.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal dropped inside of the delivery device.Another product was used to complete the procedure and no patient injury was reported.
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Search Alerts/Recalls
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