Model Number 0998-00-0800-53 |
Device Problems
Device Displays Incorrect Message (2591); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device ((b)(4)): a getinge field service engineer (fse) evaluated the iabp unit and the alarm log was showing several rapid gas loss alarms as indicated by the customer, but the fse was unable to duplicate "loss of gas" alarm.The fse did notice a clicking noise coming from compressor and replaced the compressor as a precautionary measure.The unit passed all functional and safety tests according to factory specifications and was returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had a gas loss in iab circuit alarm.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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The removed compressor was returned to the failure analysis and testing department for investigation.The national repair center installed the compressor into the cardiosave test fixture and tested the compressor to factory specifications per procedure and the cardiosave service manual.The nrc was unable to verify the failure of the compressor "clicking noise" during use.Retaining the compressor in the nrc per procedure.
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Event Description
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N/a.
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Search Alerts/Recalls
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