Primus anaesthetic workstation 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/040

CON2031245

2007-05-23

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031245

Potential misconnection of the backup oxygen cylinder; the oxygen cylinder inlet is situated alongside an oxygen outlet and both are fitted with the same connector.  a misconnection to the oxygen outlet would prevent backup oxygen supply in the event of oxygen pipeline failure. the use of an oxygen backup cylinder is optional on the primus.  if the backup cylinder is required the user must attach the cylinder, connect its oxygen nist fitting and connect the gas pressure sensor before use.  the primus has the further user option of an oxygen outlet, which is slightly longer and situated alongside the oxygen cylinder inlet fitting at the back of the primus.  this oxygen outlet is the same nist fitting as the oxygen inlet beside it and therefore users can connect the oxygen cylinder to the wrong fitting. the mhra has received a report of this misconnection, which was not detected in the device’s automated pre-use checks or the pre-use checks recommended by the aagbi (association of anaesthetists of great britain and ireland).  the oxygen pressure gauge indicated that the backup oxygen cylinder was full so the misconnection was not apparent to the user.

Ensure the backup oxygen cylinder’s NIST (non-interchangeable screw threaded) fitting is connected to the appropriate oxygen inlet.  The correct connection guide can be found above the gas inlet block at the back of the device. Users are recommended that pre-use checks should include the disconnection of the oxygen pipeline to ensure the continuity of oxygen supply from the backup cylinder.