Model Number 0998-00-0800-53 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had fiber optic sensor module failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) performed a full preventative maintenance (pm) with calibration, safety, and functionality checks to factory specifications.The iabp was returned to the customer and cleared for clinical use.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had fiber optic sensor module failure.There was no patient involvement reported.
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Search Alerts/Recalls
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