Model Number 0998-00-0800-65 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/04/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Type of investigation not yet determined: additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) had docking error between the console and the cart and had loosened and missing nuts.There was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
A getinge field service engineer (fse) remarked as "please create a customer complaint for this out of box failure.Tighten and replace nuts where necessary so that the latching mechanism is functioning correctly".The complaint will be closed and, if new information and/or device were available, the file would be reopened and updated.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|