DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-53 |
Device Problem
Circuit Failure (1089)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/26/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Testing of actual/suspected device : during scheduled pm service the fse found that the blood back detection voltages could not be calibrated to within the required specifications.To fix the issue he replaced the solenoid driver board assembly and completed a full pm and system test.All tests passed to factory specifications and the unit was released for clinical use.A supplemental report will be submitted upon completion of our investigation.The initial reporter named in is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
|
|
Event Description
|
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp), failed the solenoid driver board.There was no patient involvement, and no adverse event reported.
|
|
Search Alerts/Recalls
|
|
|