DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-0800-52 |
Device Problem
No Display/Image (1183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) has no display or audible alarm after switching on, there is only light indication on green power button and both battery leds are showing it is charging.There was no patient involvement.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Manufacturer Narrative
|
Corrected data: b5.Updated data: b4, g3, g6, h2, h10, h11.
|
|
Event Description
|
It was reported that after the d.00 software upgradation, the cardiosave intra-aortic balloon pump (iabp) has no display or audible alarm after switching on, there is only light indication on green power button and both battery leds are showing it is charging.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|