Invacare Scanbed 750 (SB 750) with integral bed rails 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/056

CON2031558

2007-06-27

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031558

Risk of asphyxiation to children from the potential for entrapment between the wooden bed rails. these beds have been incorrectly supplied in the uk by invacare and its distributors as suitable for children, due to an error in the pre-sales literature. a total of 1077 beds, complete with bed rails, have been sold throughout england and users are unlikely to be aware of the potential for entrapment of children. the manufacturer is unable to trace all these beds. this electric profiling bed is not intended by the manufacturer for occupants under 12 years of age (this may also include small adults of a similar size). this is because of possible head, neck or chest entrapment in the 120 mm space between the integral wooden bed rails. a gap of 120 mm is the maximum stated in standards for bed rails for adults. there are no british standards specifically for beds or bed rails for children. however, the general requirements standard for assistive technology products, bs en 12182, states that the maximum space to avoid entrapment of children’s heads in static equipment is 60 mm. although no injuries have been reported to the mhra, there is the potential for serious or fatal entrapment of a child to occur. the manufacturer has recently updated the pre-sales literature and has issued a field safety notice to clarify this limitation in use. this medical device alert supplements the general information given in db2006(06) ‘safe use of bed rails’, and mda/2007/009 ‘bed rails and grab handles’, both of which can be obtained from our website. to navigate from the mhra home page: www.Mhra.Gov.Uk > publications > safety guidance > device bulletins www.Mhra.Gov.Uk > safety information > safety warnings, alerts and recalls.

Trace all Invacare Scanbed 750 (SB 750) beds with integral bed rails. Provide child occupants with an alternative bed. Ensure procedures are in place to avoid children using these beds in the future.