It was discovered that when in “skin-temperature control mode” on Babytherm thermometers, if the temperature sensor is not connected to, or detaches from, the patient, the heating element can cause overheating.
This overheating can cause particles to detach, releasing hot particles. This can lead to a fire and could cause patients harm or even death.
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided advice and warnings as a result of the findings.
Actions that need to be carried out
Due to the health risk that these thermometers may carry, actions needs to be taken to reduce the risk of an incident occurring.
All users of the Babytherm® 8004/8010 Infant Warmer must be identified and all users must receive the manufactures’ Field Safety Notice and acknowledge that they understand the risk of using the device, and the advice being given by the manufacturer.
Users of the device are being told to use the manual mode instead of the “skin-temperature control mode”. If the control mode is used, however, the temperature sensor needs to be secured to the patient before it is used. This has been advised by the manufacturer’s Field Safety Notice.
The Field Safety Notice now needs to be included with the Babytherm® 8004/8010 user’s manual as well as a copy of the supplementary guidance. A Field Safety Notice also needs to be returned to Draeger UK.
These actions must be carried out between 30th August and 13th September 2016 by all healthcare workers and carers who use these devices.
Draeger is an international leader in medical and safety technology. Draeger products are supposed to be all about supporting and saving lives – whether they are being used in clinical, mining or industrial applications or different rescue services. Here, they may have fallen short given the risk of injury to patients.
In the event of injury caused to any patient, our Group Action Lawyers and Medical Negligence Lawyers can advise you of your rights.
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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