Datascope Expert Cardiac Output Module

Name: Datascope Expert Cardiac Output Module
Brand: Datascope
SKU: Expert Cardiac Output Module

Datascope · Model Expert Cardiac Output Module

Datascope Expert Cardiac Output Module is classified as Modules (Patient Monitoring). No manufacturer description has been sourced for this model yet.

Technical Specs

Weight: 7 lbs

Documents & Manuals

View spec sheet (PDF)

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

RECALL
Potential Endotoxin Contamination
RECALL
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
RECALL
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
RECALL
Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
RECALL
Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
RECALL
Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
RECALL
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
RECALL
The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

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Safety & Recalls

Synced live from the FDA openFDA API.

RECALL

Potential Endotoxin Contamination

RECALL

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

RECALL

The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.

RECALL

Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.

RECALL

Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.

RECALL

Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

RECALL

Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.

RECALL

The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.