INFINITY ACUTE CARE WORKSTATION (2021-08-17)

Starting date:

August 17, 2021

Posting date:

September 10, 2021

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-76407

Last updated:
2021-09-10

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  Reason
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  Affected products

Affected Products

1. INFINITY ACUTE CARE WORKSTATION CRITICAL CARE
2. INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE

Reason

Draeger has become aware of Sporadic cases in which the affected products with sw2.60 And lower with installed co2 measurement option restarted.

A restart is a designed system recovery function to restore the proper function of the ventilator. In the rare reported cases, however, an error in the data processing of the activated Co2 measurement caused the restart of the ventilation unit. Devices without integrated or with disabled co2 measurement function are not affected. The behavior can be effectively prevented by not activating the integrated Co2 measurement. If necessary, external Co2 monitoring can be used.

Affected products