Cardiohelp-I (2013-09-04)

Starting date:

September 4, 2013

Posting date:

September 27, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-35915

• Reason
• Affected products

Recalled products

A. Cardiohelp-I 

Reason

In certain rare instances the Cardiohelp-I device may display an error message with audible alarm indicating "battery defective". The alarm will occur while booting or when the main power supply is unplugged from the main power source. This is due to a defective capacitor within the battery manager board. Further, when alarming the HMI (Human Machine Interface) will gradually become black due to the HMI back light shutting down. The defective capacitor behavior leads to the shutdown of the battery booster that boosts the voltage of the batteries from 12v to 24v. This in turn leads to the state that the voltage is insufficient to ignite the backlight of the display. Blood flow is not affected during the shutdown time of the HMI, therefore there is no risk of circulatory impairment.

Affected products