Zeus IE Anesthesia Workstation (2019-03-11)

Starting date:

March 11, 2019

Posting date:

April 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69484

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

Zeus IE Anesthesia Workstation

Reason

Cases have been reported where the gas measurement of Zeus IE Anesthesia workstations became inactive. Draeger analysis revealed that the deactivations were caused by a too strict supervision of the sample gas pumps which are used in the gas measurement modules. As the characteristic of the pump changes with their usage time, the supervision system deactivates the gas measurement and a corresponding alarm message appears. Consequently, the probability of a gas measurement deactivation is correlated with the total usage time of the sample gas pumps. Long-term tests clearly indicate that the gas measurement is reliable for approximately 7 months assuming an average runtime of 84 hours per week. From that point on the probability of a deactivation increases beyond initial estimations.

Affected products