SAFETY ACTION NOTICE

By arrangement with the Scottish Executive Health Department

COMARK DILIGENCE EV THERMOCOUPLE DATA LOGGERS: POTENTIAL LOSS OF QUALITY CONTROL DATA
SUMMARY

SAN(SC)04/18 26 APR 2004 Medical Devices Page 1 of 1 Pages

Comark Diligence EV thermocouple data logger models N2004 and N2014 manufactured before December 2003 may lose quality control data. A software upgrade is required. BACKGROUND 1. Comark Diligence EV thermocouple data loggers are used to retain quality control data (temperature and humidity) from freezers in which human bone, other tissues and blood are stored. The data are downloaded to a PC through a docking station. 2. A random fault has been identified on data logger models N2004 and N2014 in which temperature data may be lost permanently due to hang up while downloading. 3. This fault only affects data loggers sold in the UK from the product launch in November 2001 until December 2003, with serial numbers up to and including 11030199. Data loggers sold after December 2003 with serial numbers 11030200 and above are not implicated. 4. Comark Limited has identified that the fault is due to a software problem. They have notified their healthcare and pharmaceutical customers and a software upgrade is being offered free of charge. ACTION 5. This notice should be brought to the attention of all appropriate managers, staff and users. 6. Comark Diligence EV thermocouple data logger models N2004 and 2014 with serial numbers up to and including 11030199 should be identified. 7. Comark Limited should be contacted to arrange for the return of implicated data loggers for a free software upgrade. ENQUIRIES Enquiries to the manufacturer should be addressed to: Mr David French, Comark Limited, Comark House, Gunnels Wood Park, Gunnels Wood Road, Stevenage SG1 2TA Tel: 01438 367367 Fax: 01438 367400 E-mail: david.french@comarkltd.com
Suggested Distribution Medical Physics Blood Transfusion Pharmacy Estates/Facilities Risk Management Laboratories Supplies Emergency 0131 552 6380 Helpline 0131 551 8333

SCOTTISH HEALTHCARE SUPPLIES Trinity Park House Edinburgh EH5 3SH

A Division of the Common Services Agency for NHSScotland

This notice was obtained from the INCIDENT REPORTING & INVESTIGATION CENTRE (public) website http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html
FAX: 0131 559 3922 E-MAIL: iric@shs.csa.scot.nhs.uk
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