Catalog Number 0998-UC-3013-53 |
Device Problem
Display or Visual Feedback Problem (1184)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the iabp need replacement of the display pcb and video receiver pcb.Additional information has been requested, and we will report accordingly if it becomes available.
|
|
Event Description
|
It was reported that the cs300 intra-aortic balloon pump (iabp) display is flickering.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
|
|
Event Description
|
It was reported that prior to use the cs300 intra-aortic balloon pump (iabp) display was flickering.There was no patient involvement and no adverse event was reported.
|
|
Manufacturer Narrative
|
The getinge field service engineer (fse who previously evaluated the unit reported that the issue has been rectified.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
|
|
Event Description
|
It was reported that the cs300 intra-aortic balloon pump (iabp) display is flickering.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
|
|
Search Alerts/Recalls
|