DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The stm replaced the top lcd display assembly and related labels to correct the issue.The stm also noted residual saline damage which may have caused the reported issue.The stm replaced the backplane to coiled cord cable and the front end board due to the saline damage then completed pm service.All safety, functionality, and calibration checks were performed and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the lcd display for the cardiosave intra-aortic balloon pump (iabp) had a horizontal line.Since the event occurred during pm, there was no patient involved and no adverse event was reported.
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