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:

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