Health product recall

Hamilton Medical AG Breathing Set MRI

Last updated

Summary

Product
Hamilton Medical AG Breathing Set MRI
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Breathing Set MRI Not applicable. 260167
Breathing Set MRI Not applicable. 260168

Issue

Certain lots of the expiratory valve set pre-assembled to the breathing circuit set, coaxial (see FSN) do not perform as intended. In some cases, the expiratory valve membrane adhered to the expiratory valve body's sealing ring, thereby impairing valve opening and expiratory gas flow. The issue is not detected during the pre-operative test of the ventilator unless a test lung is actively ventilated. In case of an adhering expiratory valve membrane, the malfunction appears within the first breaths after ventilation is initiated. 

When the expiratory gas flow is impeded, the end-expiratory pressure is too high, or the end-expiratory flow is too low. Consequently, the ventilator triggers the high priority alarm "Exhalation Obstructed". 
The obstructed air is released through the device, e.g.the obstruction valve opens so that the patient can exhale through the inspiratory limb.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Hamilton Medical AG

Via Crusch 8, Bonaduz, Switzerland, 7402

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82133

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe