The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Resuscitation Systems with blender field upgrade installed in Giraffe and Panda Warmers, manufactured by GE Healthcare.
According to the manufacturer, GE Healthcare has recently become aware of a potential safety issue concerning the affected product where the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. As a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. The settings of the blender knob will no longer be accurate.
The manufacturer recommended users to follow the instructions shown in the field safety notice to identify the affected resuscitation system. Regarding affected unit in use with patient, the manufacturer advised users to disconnect the wall supply gas and switch to tank supply. Once the patient no longer requires respiratory support, the patient should be transferred to another bed and the unit should be removed from service.
The manufacturer will also arrange on-site repair for all affected devices.
For details, please refer to MHRA website http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON195935
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 31 October 2012