DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-UC-3013-53 |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: the getinge field service engineer fse that evaluated the iabp found that the display video receiver was not working.A supplemental report will be submitted if additional information is received.The initial reporter name was shortened due to field character limit and should read: (b)(6).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): phone number: (b)(6).A separate mdr will be submitted to report the autofill failure issue.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs100 unit display was flickering and with demo balloon system showing autofill error.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The getinge field service engineer (fse) that found the problem replaced the pm 5000 hours kit.The fse then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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N/a.
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Search Alerts/Recalls
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