DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).During a pm service, the getinge field service engineer (fse) found fault code 139 in the log; it was logged 5 times.To fix the issue, the fse reseated the boards and pumped for two hours and the alarm was not reproduced.The fse completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
|
|
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) had fault code 139 message.There was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
Updated fields: b4, e1 (event site email), g3, g6, h2, h6 (component codes, health effect impact codes), h10.
|
|
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) had fault code 139 message.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) had fault code 139 message.There was no patient involvement, and no adverse event reported.
|
|
Search Alerts/Recalls
|
|
|