Model Number 0998-00-0800-53 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that during inspection, the cardiosave intra-aortic balloon pump (iabp) unit has drive manifold leak error.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse replaced the drive manifold assembly.The fse completed the inspection with good results.
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Event Description
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N/a.
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Manufacturer Narrative
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The failure analysis and testing dept.Received part number 0104-00-0031 rev.J, serial number (b)(6) with a reported unit failure of a drive manifold leak error.The fat performed a visual inspection and found the part to be in good condition.The fat installed the manifold in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual.Confirmed that the part failed the drive manifold leak test.No root cause defined.Sending the board to the supplier for failure analysis per procedure.
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Event Description
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N/a.
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Manufacturer Narrative
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**udi related data quality updates only** providing updated device identification information in alignment with gudid.
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Search Alerts/Recalls
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