The Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom posted a medical device safety alert concerning Manual and Automatic Resuscitation System II, manufactured by GCE.
The affected devices are identified as follow:-
The manufacturer has identified a potential problem with the properties of the diaphragm which is mounted to flow sensor to the product MARS II, with the above GCE final item numbers, production batches and serial numbers. There can be a potential problem with functionality of the diaphragm and also functionality of complete product in the automatic mode. The diaphragm may not function properly and thus may adversely affect the functionality of the product in this automatic mode. In the manual mode the product is functional.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-18-april-to-22-april-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 April 2016