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Health product recall

Draegerwerk Oxylog (2015-12-23)

Starting date:
December 23, 2015
Posting date:
April 29, 2016
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-58108

Affected Products

A. OXYLOG 3000

B. OXYLOG 3000 PLUS

C. OXYLOG 2000 PLUS

Reason

Draeger has become aware of situations where the error message "poti unplugged" was generated. In these cases, an acoustic and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. Draeger's investigation showed that the error message is caused by increased electrical contact resistance of the controllers (adjustment potentiometers). The increased resistance is the result of an oxide layer on the controllers, which accumulates over a long period of time. This oxide layer can only accumulate if the controllers are moved rarely or never. Draeger's product monitoring has shown that some users rarely use the controller or do not use it at all.

Affected products

A. OXYLOG 3000

Lot or serial number

All lots.

Model or catalog number

2M86955

Companies
Manufacturer

DRAEGERWERK AG & CO

MOISLINGER ALLEE 53-55

LUBECK

23542

GERMANY



B. OXYLOG 3000 PLUS

Lot or serial number

All lots.

Model or catalog number

5704811

Companies
Manufacturer

DRAEGERWERK AG & CO

MOISLINGER ALLEE 53-55

LUBECK

23542

GERMANY



C. OXYLOG 2000 PLUS

Lot or serial number

All lots.

Model or catalog number

5705081

Companies
Manufacturer

DRAEGERWERK AG & CO

MOISLINGER ALLEE 53-55

LUBECK

23542

GERMANY