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Cardiosave Rescue IABP (Datascope) – charging problem (2023)

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

Moderate

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – temperature alarm issue (2023)

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Moderate

FDAJul 31, 2023Nationwide• Datascope Corp.

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Cardiosave Rescue IABP (Datascope) – charging problem (2023)

Cardiosave Hybrid IABP (Datascope) – temperature alarm issue (2023)

Perifix Epidural Set (B. Braun) – mislabeled lid (2023)

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Commander (ROSENBAUER) – winch equipment problem (2023)

Cardiosave Rescue IABP (Datascope) – temperature alarm issue (2023)

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Ford Transit 350 (SUMMIT BODYWORKS) – fuel system issue (2023)

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