Field Safety Notice GE Healthcare Flow Sensors with Potentially Damaged Tubes in GE Healthcare / Datex-Ohmeda Anaesthesia Machines (ICN 1440)

MHRA TBA
NHSSC Ref: 55
GE Healthcare Ref #3420

Alert:

• GE Healthcare internally identified that a small number of flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts.
• These could cause leaks resulting in incorrect anaesthesia machine tidal volumes potentially leading to over delivery of volume to the patient.
• There have been no injuries reported as a result of this issue.

Products Affected:
One of the products affected is available from NHS Supply Chain as:

• NPC: FDB749
• Product Description: Flow Sensor
• Supplier Code/MPC: 2089610-001-s
• Supply Route: Blue Diamond.

Next Steps:

• Always complete a pre-operative check, please refer to the Field Safety Notice for full details.
• Inspect all inventory of flow sensors, including those installed in anaesthesia machines, spare inventory, reprocessing locations and, other locations not in use.
• Follow the instructions to check for the date of manufacture on the flow sensor body, not the packaging.
• If the date of manufacture is “2101-06” or later the flow sensor is not affected and can continue to be used.
• If the date of manufacture is prior to “2101-06” this flow sensor is affected. These can be either destroyed or returned at no cost to you to GE Healthcare who will replace all affected sensors.
• If you only have affected flow sensors these can continue to be used after you have successfully completed the pre-operative checks detailed in the Field Safety Notice.
• Complete the Medical Device Correction Confirmation Form, page 4 of the Field Safety Notice return as directed to FM134120.FLOWSENSOR@GE.COM.
• Contact your local GE Healthcare Sales or Service Representative with any questions or to expedite the replacements.
• For further information contact UK Technical Support Representative on telephone 01707263570 or email askuktechnicalsupport@ge.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.