Model Number 0998-00-0800-55 |
Device Problem
Failure to Read Input Signal (1581)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Type of investigation not yet determined: a supplemental report will be submitted if additional information is provided.Full event site name: (b)(6).
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Event Description
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It was reported that the touch screen in the cardiosave intra-aortic balloon pump (iabp) was not working.It is unknown under which circumstances this 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) was dispatched to evaluate the iabp.The fse reported that compressor failures were detected upon review of the system, which indeed presented problems on the touch screen.Numerous tests were performed and some materials were replaced: the touch screen was replaced and calibration tests was performed.The fse informed that the compressor was replaced latter after it was received.The calibration of the pressure vacuum regulators and pneumatic performance tests of the compressor were carried out.As well as the whole set.The fse stated that the iabp is in correct working order.
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Event Description
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It was reported that the touch screen in the cardiosave intra-aortic balloon pump (iabp) was not working.It is unknown under which circumstances this event occurred.There was no patient involvement and no adverse event was reported.
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Manufacturer Narrative
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All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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Manufacturer Narrative
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Updated fields: b4, g3, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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