Catalog Number C-HSK-3038 |
Device Problem
Device Difficult to Setup or Prepare (1487)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm did not load properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm did not load properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
Internal complaint- (b)(4).Autonumber # (b)(4).
|
|
Search Alerts/Recalls
|