DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Connection Problem (2900)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Type
Injury
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was reviewed and no non-conformances related to the reported event were noted the field service engineer (fse) arrived onsite and tested the unit for proper autofill and pumping.The stm also inspected the service mode for any electrical alarms or any other alarms and none were found.The fse performed safety test and all manifold test which passed per factory specifications.However, due to the customer's complaint, the fse replaced the ecg leads and released the iabp to customer for clinical use.
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Event Description
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It was reported by customer that during intra-aortic balloon pump (iabp) therapy, the cardiosave intra-aortic balloon pump (iabp) shocked the patient through ecg leads.However, the customer indicated that the patient did not sustain any harm from the shock.Refer to mfg report number 2248146-2020-00211 for information on the involved intra-aortic balloon catheter (iabc).
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.
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Event Description
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It was reported by customer that during intra-aortic balloon pump (iabp) therapy, the cardiosave intra-aortic balloon pump (iabp) shocked the patient through ecg leads.However, the customer indicated that the patient did not sustain any harm from the shock.Refer to mfg report number 2248146-2020-00211 for information on the involved intra-aortic balloon catheter (iabc).
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