Catalog Number 0998-00-0800-53 |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/29/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The stm replaced the pneumatic module assembly to remedy the malfunction and completed the preventive maintenance with full calibration.The iabp then passed all functional and safety tests per factory specifications and was returned to customer and cleared for clinical use.
|
|
Event Description
|
A getinge service territory manager (stm) reported that while performing preventive maintenance on the cardiosave it failed the patient module leak test and had no alarms.No patient involvement or adverse event was reported.
|
|
Search Alerts/Recalls
|