Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
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| Issued: 13 December 2006 at 15:00 |
Ref: MDA/2006/068
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Physiological monitor: Smiths Medical 3404 BCI® AUTOCORR® Plus pulse oximeter/ECG/respiration monitor. |
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| Problem: Noisy or no display of SpO2, ECG or respiration readings. This is due to a faulty component in a known group of devices. |
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| Action by: Anaesthetists, operating theatre practitioners, intensive care, A&E, ambulance and technical staff. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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| Appendix: Smiths Medical Safety Action Bulletin (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 28 December 2006
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Deadline (action complete): 15 January 2007
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