DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Output below Specifications (3004)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/28/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.
The field service engineer (fse) performing preventative maintenance (pm) stated the compressor rpm was greater than 2000 as part of compressor output test.
The compressor would take about 30 seconds to build pressure to 390 mmhg, as part of calibration subsequently, the compressor raised pressure to 416 mmhg maximum.
The fse did not observe anything unusual in the logs.
To address the issue the fse replaced the scroll compressor and filters and completed pm.
The unit was then calibrated and passed all functional and safety tests per factory specifications.
The iabp was returned to customer and cleared for clinical use.
(b)(6).
|
|
Event Description
|
It was reported that during a preventative maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) had a compressor output test failure.
There was no patient involvement, and there was no adverse event reported.
|
|
Search Alerts/Recalls
|
|
|