Field Safety Notice GE Healthcare Flow Sensors with Potentially Damaged Tubes in GE Healthcare / Datex-Ohmeda Anaesthesia Machines (ICN 1440)
Important Customer Notice Field Safety Notice
Ref: 2021/1440 ICN Number: 1440
NHSSC Ref: 55
GE Healthcare Ref #3420
- 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.
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.
- 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 email@example.com.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.