Model Number 0998-00-0800-53 |
Device Problem
Break (1069)
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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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Event Description
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It was reported that during preventative maintenance by getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) unit's case is damaged.There was no patient involvement.
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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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Additional poc - (b)(6).Fse resolved the issue by replacing the console cover.Fse then completed full pm and tested the functionality and safety of the device and iabp was then returned to customer for clinical use.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing department received and inspected a console cover and observed the back of the console is cracked/broken in the screw holes.No further test can be done due to the cracked/broken console cover.Retaining the console cover in the failure analysis and testing department per procedure (b)(4) rev ap.The root cause selection for this investigation will be ¿impossible to define¿ due to the department not having the capabilities to troubleshoot this part internally further in an attempt to determine the root cause.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
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Search Alerts/Recalls
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