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Documentos

CS100-CS300 IABP: Battery operation

Quick reference guide

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Documentos

Customer letter for four identified issues, July 31, 2023

Voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) related to Autofill Alarms, Gas Loss & Gas Gain Alarms, System…

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Documentos

Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS

Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS

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Documentos

JAN2023 783344 Safety Disks

This is a new recall, separate from the earlier reported recall involving four (4) issues regarding unexpected shutdown and helium leaks. Datascope Corp., a subsidiary of Getinge is…

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Documentos

MCA000000556 C_US_Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation

MCA000000556 C_US_ Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation

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Documentos

Signature_Banner_IABP_Product_Support_Page_MCA00003220 Rev A_OUS

Signature Banner IABP Product Support Page MCA00003220 Rev A for OUS use

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Documentos

MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories

MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories, HL40, Collagen ISO 13485:2016 Effective: 2023-02-06 Exp. 2026-02-05

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Documentos

UPDATED - Urgent Medical Device Product Correction

Cardiosave Intra-Aortic Balloon Pumps (IABP) performance issues – Version 2

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Documentos

Updated Guidance for Managing the Cardiosave IABP Customer Presentation

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Documentos

CS300 IABP: Operation and insertion of balloon

Quick reference guide

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