Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has issued a medical device safety alert concerning Babytherm infant warmers [Model no.: 8000WB, 8004 and 8010], manufactured by Dräger Medical GmbH.
The manufacturer became aware of a case in which a side panel on a Babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. The side panel did not open during this incident and no patient was affected. When reviewing the locking mechanism in a number of hospitals, it was possible to fully close the side panels by pushing down on them slightly. However, it cannot be guaranteed that the panel will lock in to position under its own weight.
Affected users should contact the manufacturer, if they have found that the locking mechanism is not functioning. The manufacturer is advising affected users to pay attention to the information provided in the Instructions for Use (IFU): "Check that the side panels lock securely into position and that they remain securely locked"
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON448384
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 Sep 2014