Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning GE Medical Systems 9100c NXT and Aelite NXT anesthesia devices with CSB boards manufactured prior to June 2020 [multiple serial number][HKMD No.: 180041].

According to the MHRA, the manufacturer is informing users of an issue regarding 9100c NXT and Aelite NXT anesthesia devices with CSB boards manufactured prior to June 2020 have resistors that could potentially fail due to electrolytic corrosion.

• If the resistor fails during system checkout, “System malfunction – C8 error” will appear on the display and the system will not move to mechanical ventilation and in this case the system cannot be used.
• If the resistor fails during use, “System malfunction – C8 error” will appear on the display and mechanical ventilation will stop. In the unlikely situation that this issue is not identified and addressed by the attending clinician, the loss of ventilation can be life threatening.

For further information, please visit https://mhra-gov.filecamp.com/s/X5FLC0fRZ5w11ZQx/d

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 5 Oct 2022