DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-0800-53 |
Device Problem
Failure to Charge (1085)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/10/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) was not charging.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
|
|
Manufacturer Narrative
|
At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A getinge field service engineer (fse) solved the problem by phone and facetime, the fse verified that the cart was plugged in, but he recognized that the console was not seated properly in the cart.The fse instructed the customer to reseat the cart and verified that the unit was charging, he then returned the unit cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, g1(contact person).
|
|
Search Alerts/Recalls
|
|
|