DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Moisture or Humidity Problem (2986)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and found trace amount of condensation in the patient interface module.The stm performed the condensation removal procedure to resolve this issue.The stm also found chewing gum stuck on caster, causing the unit to wobble while rolling.The stm removed the chewing gum from the caster to resolve this issue.The stm then performed full functional and safety checks.The iabp unit passed all functional and safety checks per factory specifications, was returned unit to the customer and cleared for clinical use.
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Event Description
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It was reported that during use on a patient, the user observed condensation in the balloon tubing of the cardiosave intra-aortic balloon pump (iabp).In addition, it was reported that a caster was wobbling.There was no patient harm or adverse event was reported.
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Search Alerts/Recalls
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