Maquet Critical Care Servos U and N (2014-04-17)

Starting date:

April 17, 2014

Posting date:

May 8, 2014

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-39385

• 
  Reason
• 
  Affected products

Recalled Products

A. Servo-U

B. Servo-N

Reason

We have had one occurrence of a disconnection from the ventilator tubing, which was not detected by the ventilator, (i.e. No alarms were triggered.) This absence of alarms may occur with system version 1.00.05 in "invasive ventilation modes", in "adult and pediatric patient categories" and with the low peep alarm turned off by setting it to zero. This absence of alarms does not occur in the neonatal patient category, or in non-invasive modes. This absence of alarms does not occur in system version 1.00.06, which is readily available.

Affected products