DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: getinge field service engineer (fse) was dispatched to evaluate this unit.The customer was advised to charge the unit overnight.The fse arrived at the customer site the next day to test the unit and observed that unit did shut off after charging the batteries overnight.The fse replaced the batteries and advised customer to charge batteries overnight.A supplemental report will be submitted upon receipt of additional information.
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) had a unit shut down.It is unknown under which circumstances this event occurred; however, there was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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Updated fields - e1(site country), h6 (type of investigation, investigation findings, component codes, investigation conclusions).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had a unit shut down.It is unknown under which circumstances this event occurred; however, there was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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