ErgoStar CM 45 and ErgoStar CM 55
Brand(s)
Last updated
Summary
Product
ErgoStar CM 45 and ErgoStar CM 55
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 |
|---|---|---|
| ErgoStar CM 45 | More than 10 numbers, contact manufacturer. | MP01845-XX |
| ErgoStar CM 55 | More than 10 numbers, contact manufacturer. | MP01855-XX |
Issue
The action is being initiated due to a potential issue with the smoothbore hoses of the catheter mounts. Under stress, these hoses could tear, potentially resulting in leakage. If leakage occurs, the ability of ventilators or anesthesia devices to compensate depends on the size of the leak and the ventilation pressure settings. In cases where compensation is not possible, ventilation may be restricted, posing a risk of desaturation or hypoxia for the patient.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Draegerwerk Ag & Co. Kgaa
Moislinger Allee 53-55, Lubeck, Germany, 23542
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78457
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