Model Number 0998-00-0800-55 |
Device Problem
Failure to Charge (1085)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/25/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).During a pm service, the getinge field service engineer (fse) discovered the batteries would not charge needed to be replaced before the end of life.To fix the issue, the fse replaced the ion batteries.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 during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) battery would not respond after charging for a while.There was no patient involvement, and no adverse event reported.
|
|
Event Description
|
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) battery would not respond after charging for a while.There was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
Updated fields: b4, e1 (event site address, event site city, event site telephone), g3, g6, h2, h10.The pm was completed with all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
|
|
Manufacturer Narrative
|
The getinge field service engineer (fse) discovered the batteries would not charge needed to be replaced before the end of life.To fix the issue, the fse replaced the ion batteries and replaced the o-ring as needed for pm.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
|
|
Event Description
|
N/a.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|