Model Number HST III SYSTEM (3.8MM) |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise 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.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) failed to load properly.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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(b)(4).A lot history record review was completed for lots 25154058, 25154076, 25154132, the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) failed to load properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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