Model Number 0998-00-0800-53 |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted as the result of a retrospective review conducted in capa 584165.A supplemental report will be submitted when the evaluation is completed.
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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) displayed condensation in the tubing.Customer did not observe any evidence of blood contamination.No patient harm, serious injury or adverse event was reported.
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) advised customer during a service call that condensation is due to operation and climate conditions.Customer will clear condensation from extension tubing as per operation protocol.No service visit was required, resolved issued over the phone.H3 other text : evaluation not requested by complainant.
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Search Alerts/Recalls
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