Sokinox No Delivering And Monitoring System

Starting date:
June 30, 2017
Posting date:
July 18, 2017
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-64016

Reason

Due to a pressure increase after the cylinder switch-over, there are 2 possible issues identified:
1. The cylinder status icon can change and erroneously indicate remaining gas in an empty NO(nitric oxide) gas cylinder.

2. The alarm "no cylinder 1 missing (or empty)" or "no cylinder 2 missing (or empty)" can be deactivated.  If the empty no cylinder is not replaced, both no cylinders can run empty and cause a stop in no delivery. There have been no reports of patient injury as a result of this issue.

Affected products

Sokinox No Delivering And Monitoring System

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

6694550

Companies

Manufacturer
Maquet Critical Care AB
Rontgenvagen 2
Solna