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
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a routine check performed by a getinge field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) was showing low battery.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit for the reported battery issue and was able to reproduce the reported issue.To fix the issue the fse replaced the battery and verified that it was charging, he then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.(b)(6).The initial reporter named 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), biomed.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d1, d4, g1 (contact person ¿ mfg site).
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Event Description
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N/a.
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Search Alerts/Recalls
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