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Ref. MDA/2005/055
Issued: 18 October 2005
| IMMEDIATE ACTION | |
| ACTION |  |
| UPDATE | |
| INFORMATION REQUEST |
| Further Information | |||||||||
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| DEVICE: Nellcor N-595 pulse oximeters N-395, NPB-290 and NPB-295 pulse oximeters (with serial numbers after G01844386). |
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| PROBLEM: The failure rate of the loud speaker component in N-595 and some N-395, NPB-290 and NPB-295 pulse oximeters is higher than expected. This may result in the monitor losing its audio alarm. Neither the visual nor remote alarm functions are affected. |
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| ACTION BY: All nursing and medical personnel using these devices. |
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| ACTION: Users should be aware of this problem and the appropriate action to take, (see Appendix for manufacturer's letter), to test the alarm system and have the corrective action undertaken if required. |
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DISTRIBUTED to:
* via CE Bulletin |
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| CONTACTS: Details of manufacturer contacts, MHRA contacts for technical and clinical aspects. Change of address or removal from address list for CSCI (and Healthcare Commission). |
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> Further information supplied in the following pages.
MDA/2005/055 - Nellcor N-595 pulse oximeters N-395, NPB-290 and NPB-295 pulse oximeters (with serial numbers after G01844386) 
