Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Hill-Rom Dynamis and Gerialit Beds with DEWERT electrical system

29 Jan 2013

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Dynamis and Gerialit Beds manufactured between October 1995 and June 2001 with DEWERT electrical system, manufactured by Hill-Rom. The affected model numbers are LI146B1—LI146BI, LI146D1—LI146DI, LI147B1—LI147D1, LI150A0—LI150B0, LI163B1—LI163C1, PRS0128, PRS0199, PRS0201, PRS2001.

The manufacturer wants to make aware of a potential safety issue regarding Dynamis and Gerialit beds manufactured and shipped from October 1995 to June 2001 that have Dewert control boxes. It is possible for there to be unintentional movement of the bed when it is plugged in, including sudden collapse to the lowest position.

In an effort to mitigate the potential for injury, the manufacturer requested customers that the labels should be applied to both sides of the bed as a reminder where a hand should not be placed, and to not climb under the bed. The manufacturer also advised customers to make sure that staff, patients, caregivers, and visitors do not work or crawl under any bed or other areas where unintended quick return to lowest position or collapse of the bed could cause entrapment that serious injury of death could occur.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON226926

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 29 January 2013

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