Device product
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Z-0939-2013
Product summary
- Event
- Event 64447
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260
- Official record key
device-enforcement:Z-0939-2013
Official wording
Reason: 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.
Code information: Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Distribution pattern: Distributed in the states of CA, IL, and MA.
Derived failure modes
-
Unknown
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.