VentStar Heated (Neonate), Helix Dual Heated, Helix Heated, Dual H N Plus & Infinity ID Beathing Circuit Heated (Neonate) (2020-05-12)
- Starting date:
- May 12, 2020
- Posting date:
- May 22, 2020
- 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-73163
Last updated: 2020-05-20
Affected Products
A. VentStar Heated (Neonate)
B. Infinity ID Beathing Circuit Heated (Neonate)
C. VentStar Helix Dual Heated
D. VentStar Helix Heated
E. VentStar Helix Dual H N Plus
Reason
Dräger has become aware of a case in which a VentStar Helix heated breathing circuit was operated used together with a Fisher & Paykel MR810 humidifier. This product combination is not approved. The humidifier used did not detect previously unexplained damage to the heating wire of the VentStar Helix Heated. This led to the ignition of the breathing gas and the affected patient suffered burns if Dräger breathing circuits are used with humidifiers other than the Fisher &Amp; Paykel MR850 humidifier indicated in the instructions for use, patients and/or users can be injured if an error occurs.
Affected products
A. VentStar Heated (Neonate)
Lot or serial number
All lots.
Model or catalog number
MP00308
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY
B. Infinity ID Beathing Circuit Heated (Neonate)
Lot or serial number
All lots.
Model or catalog number
MP00343-XX
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY
C. VentStar Helix Dual Heated
Lot or serial number
All lots.
Model or catalog number
MP02606
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY
D. VentStar Helix Heated
Lot or serial number
All lots.
Model or catalog number
MP02607
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY
E. VentStar Helix Dual H N Plus
Lot or serial number
All lots.
Model or catalog number
MP02650
Companies
- Manufacturer
-
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lübeck
23542
GERMANY