Model Number 0998-00-0800-52 |
Device Problems
No Display/Image (1183); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
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 use on a patient, the cardiosave intra-aortic balloon pump (iabp) units screen has gone black and is not working at all.There was no patient harm reported.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) units screen has gone black and is not working at all.Additional information received indicated the iabp shut down and stopped working mid way through therapy while on mains power.There was no patient harm reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional fields: e1 (event site state: (b)(6), event site postal code: (b)(6)).It was reported that the cardiosave intra-aortic balloon pump (iabp) shut down while in use on patient - no reported harm to patient.No patient details available.A getinge field service engineer (fse) inspected system mains power ok, battery packs fully charged but system would not power up.The power management pcb was found to be fluid damaged but no fluid found in unit.Replaced power management pcb - system fully tested and returned to department.Ebme contact (b)(6) reported by (b)(6) (b)(4).
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Search Alerts/Recalls
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