VentStar (N) 180 (2021-01-19)
- Starting date:
- January 19, 2021
- Posting date:
- January 26, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74859
Last updated:
2021-01-26
Affected Products
- VentStar Anesthesia (N) 180
- VentStar Basic (N) 180
Reason
During the course of global market surveillance activities, manufacturer become aware of cases in which the Y-piece became detached from the ventilation hose either before or during the ventilation process. Further analyses determined that the Y-pieces, due to a manufacturing error, could in some cases become disconnected at tensile forces below what is specified. Consequently, some of the referenced breathing circuits may potentially show a limited lifetime of the adhesive joint. If the Y-piece becomes detached from the hose during use, a leak will be caused that can hinder ventilation of the patient. If the breathing circuit is used with devices that are listed in the instructions for use as being compatible, any leakage will be detected and the device will give an alarm. There were no reports of any adverse impact on the health of the patients in question.
Affected products
-
VentStar Anesthesia (N) 180
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MP00333
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY
B. VentStar Basic (N) 180
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MP00353
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY