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
Premature Discharge of Battery (1057)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that, the cs300 intra-aortic balloon pump (iabp) batteries failed to meet runtime spec.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Corrected data: b5, b6, b7, d5, e1(name and email), e2, e3, e4, d10, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
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Event Description
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It was reported that during preventative maintenance testing performed by a getinge field service engineer (gfse), the cs300 intra-aortic balloon pump (iabp) batteries failed to meet runtime specification.There was no patient involvement.
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Manufacturer Narrative
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The getinge field service engineer(fse) evaluated the device for the discovered issue.The fse replaced the batteries and completed a full pm.Full pm, calibration, safety, and functionality checks were completed per the service manual and passed to factory specifications.The device was returned to the customer and released 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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