DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) had an unknown issue with the 2500hr maintenance kit.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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After further review, an initial emdr for this complaint was incorrectly submitted.The complaint was created in error, being that it was a preventive maintenance and that there was no reported customer dissatisfaction related to this event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel in your database.
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Event Description
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N/a.
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Search Alerts/Recalls
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