Catalog Number 0684-00-0433 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/14/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
|
|
Event Description
|
It was reported that after intra-aortic balloon (iab) insertion that the fiber optic cable was not functioning.The pressures were monitored via an alternative method to continue therapy.There was no reported injury to the patient.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that after intra-aortic balloon (iab) insertion that the fiber optic cable was not functioning.When the staff connected the fiber optic cable to the console it did not work.The pressures were monitored via a-line to continue therapy.The indication for use was stemi (non-st-elevation myocardial infarction) & cardiogenic shock.There was no reported injury to the patient.
|
|
Search Alerts/Recalls
|