FDA-Device2013-03-20Class II

Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

Draeger Medical, Inc.
Hazard

The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.

Sold states
Distributed in the states of CA, IL, and MA.
Affected count
260
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2013

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