Infinity M540 (2018-03-19)

Starting date:

March 19, 2018

Posting date:

April 13, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66412

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  Reason
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  Affected products

Affected products

Infinity M540

Reason

Draeger learned about an issue with the infinity 540 patient monitor with software versions vg4.1 and below. When the m540 patient monitor is used with and connected to the Infinity MCable Mainstream CO2 (m11.1) sensor revision 16, the m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. If the m540 patient monitor reboots 3 times within a 10 minute period or less, the m540 patient monitor will go enter a fail-state, resulting in a resetting to factory defaults and loss of patient settings and stored patient data. Revision 16 sensors were introduced in mid-2017. Use of revision 15 and earlier sensors will not cause this issue to occur.

Affected products