SAFETY ACTION NOTICE

By arrangement with the Scottish Executive Health Department

SAN(SC)03/26
DATEX-OHMEDA QUICK CAL CALIBRATION GAS REGULATOR: 27 AUG 2003
RISK OF INCORRECT MONITOR CALIBRATION Medical Devices
Page 1 of 4 Pages

SUMMARY

Datex-Ohmeda calibration gas regulators may become partially blocked resulting in incorrect
calibration of multi-parameter monitors. Recommended precautions are outlined.

BACKGROUND

1. Datex-Ohmeda calibration gas regulators are used with QUICK CAL gas canisters to regulate the
flow of calibration gas for the calibration of multi-parameter monitors. A report was received
concerning a faulty calibration gas regulator producing an incorrect reading on the monitor. The
regulator involved is now obsolete, but the problem affects the current range of regulators.

2. Datex-Ohmeda have identified that calibration gas regulators can become faulty over a period of
time due to small aluminium and rubber particles, from the canister screw and seal respectively,
partially blocking the inside of the regulator. This results in insufficient gas being fed to the
monitor, therefore air is entrained through the regulators overflow port diluting the calibration gas.
The diluted calibration gas causes the incorrect calibration of multi-parameter monitors. Should
the monitor be recalibrated on this basis, subsequent use with patients will produce erroneously
high readings.

3. Datex-Ohmeda issued a Technical Bulletin in February 2002 (see Annexe) to alert users to this
potential problem and to provide new annual maintenance checks, however, this was not
distributed in the UK until March 2003.

4. Implicated regulators in the current range can be identified by catalogue REF 755534 (push button)
and REF 755530 (rotary control valve).

5. The obsolete regulator that was involved in the incident can be identified by REF 755533 (rotary
knob). These regulators are marked with the original equipment manufacturers reference which
starts with RA-10D-2/ and ends with a five-digit serial number.

ACTION

6. This notice should be brought to the attention of all appropriate managers, staff and users.

Suggested Distribution Accident & Emergency Anaesthetics Dental Hospitals

Health & Safety Intensive Therapy Units Medical Medical Physics
Nursing Operating Departments Risk Management

SCOTTISH HEALTHCARE SUPPLIES

Gyle Square Edinburgh EH12 9EB
A Division of the National Service Scotland for NHSScotland
This notice was obtained from the INCIDENT REPORTING & INVESTIGATION CENTRE (public) website
http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html
N:\WORD\HAZ\PUBLIC LIBRARY SAN\2003 SAN\PSAN0326.doc
FAX: 0131 314 0722 E-MAIL: iric@shs.csa.scot.nhs.uk
 SAFETY ACTION NOTICE
By arrangement with the Scottish Executive Health Department

SAN(SC)03/26
DATEX-OHMEDA QUICK CAL CALIBRATION GAS REGULATOR: 27 AUG 2003
RISK OF INCORRECT MONITOR CALIBRATION Medical Devices
Page 2 of 4 Pages

7. It is recommended that advice is followed as outlined in the Datex-Ohmeda Technical Bulletin

Ref# TB SABU HKI 02001, Datex-Ohmeda Calibration Gas Regulators, published in February
2002 (see Annexe).

8. A system should be in place for the maintenance of calibration gas regulators in line with
manufacturers instructions.

9. Regulators REF 755533 marked with the manufacturers reference, starting RA-10D-2/ and ending
in a five-digit serial number are now obsolete. These devices should be replaced with new style
regulators REF 755534.

ENQUIRIES

Enquiries to the manufacturer should be addressed to:

Mr R Gray
Business Manager
Datex-Ohmeda (Scotland)
1 Cunningham Road
STIRLING
FK7 7FW

Tel: 01786 474466

Fax: 01786 446610
E-mail: bob.gray@uk.datex-ohmeda.com

SCOTTISH HEALTHCARE SUPPLIES

Gyle Square Edinburgh EH12 9EB
A Division of the National Service Scotland for NHSScotland
This notice was obtained from the INCIDENT REPORTING & INVESTIGATION CENTRE (public) website
http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html
N:\WORD\HAZ\PUBLIC LIBRARY SAN\2003 SAN\PSAN0326.doc
FAX: 0131 314 0722 E-MAIL: iric@shs.csa.scot.nhs.uk
ANNEXE

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