Model Number HST III SYSTEM (3.8MM) |
Device Problems
Mechanical Problem (1384); Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2019 |
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.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.Device discarded.
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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) would not unlock prior to use.(fitting problem) 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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Trackwise # (b)(4).Corrected device code changed to "mechanical issue".
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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) would not unlock prior to use.(fitting problem) 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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