Model Number 0998-00-0800-53 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site was shortened due to field character limit; the full name is (b)(6).A getinge field service engineer (fse) was dispatched to evaluate this unit.The initial investigation shows that there was no helium for the unit.The fse removed the pump console from the cart and found the o-ring for the cart disconnect broken.The fse replaced the o-ring and replaced the empty helium bottle.Now the unit is holding helium.The unit passed all functional, safety, and electrical tests to factory specifications.The unit is cleared for clinical use and returned to customer.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had an error that indicated that the unit was low on helium.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: e1(site country), h6 ( type of investigation, investigation findings, investigation conclusion).Corrected fields: h6 (clinical code).
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Search Alerts/Recalls
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