HAZARD NOTICE By arrangement with the Scottish Executive Health Department

Transcription

1 HAZARD NOTICE By arrangement with the Scottish Executive Health Department CRITIKON DINAMAP PRO & PRO 1000 BLOOD PRESSURE AND VITAL SIGNS MONITORS: RISK OF ELECTRIC SHOCK HAZ(SC)02/04 Page 1 of 4 Pages SUMMARY The mains input socket can detach from the back of Critikon DINAMAP PRO and PRO 1000 Blood Pressure and Vital Signs monitors, exposing live parts. The manufacturer, GE Medical Systems, has implemented a modification programme. BACKGROUND 1. Four incidents have been reported in which the mains input socket detached from the back of the case of DINAMAP PRO and PRO 1000 Blood Pressure and Vital Signs monitors, exposing live parts. 2. In one case the unit and its mobile stand was wheeled away while the mains cable was still connected to the electrical mains supply. The input socket pulled out of the back of the case and disconnected from the internal wiring. This resulted in the input socket with exposed terminals still attached to the live cable. The nurse picked up the live cable and attempted to reconnect the monitor. 3. In another three cases the user attempted to disconnect the mains cable from the unit and the input socket pulled out of the case exposing live terminals. 4. The Company is aware of this problem and has implemented a modification programme. The UK Service Group is in the process of contacting all PRO and PRO 1000 customers and arranging for the power sockets to be glued to the rear panel. It is expected that all units will be upgraded by the end of December In the meantime, it is essential that users exercise caution when moving the monitor and disconnecting the mains cable. 5. GE Medical Systems issued an Important UK Product Hazard Notice on 13 August 2002 stating the problem and precautions to be adopted. Information on how to identify implicated monitors is given in the attachment to the Notice. The manufacturer s notice and attachment are reproduced in Appendix 1. This information, with additional details, can also be found on the IRIC website (1) or MDA website (2) (see References). 6. All implicated Dinamap monitors were sold under the name of Critikon. ACTION 7. This notice should be brought to the attention of all appropriate managers, staff and users. Suggested Distribution Accident & Emergency Anaesthetics Care Home Services Device Managers District Nursing Endoscopy Estates/Facilities General Medical Practitioners Health Centres Hospices Maternity Medical Operating Departments Out-Patients Physiological Measurement Risk Management Safety Officers Stores Supplies Wards SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: N:\WORD\HAZ\PUBLIC LIBRARY HAZ\2002 HAZ\PHAZ0204.DOC

2 HAZARD NOTICE By arrangement with the Scottish Executive Health Department CRITIKON DINAMAP PRO & PRO 1000 BLOOD PRESSURE AND VITAL SIGNS MONITORS: RISK OF ELECTRIC SHOCK HAZ(SC)02/04 Page 2 of 4 Pages 8. Users of DINAMAP PRO Series Patient Monitors and DINAMAP PRO 1000 Patient Monitors should be made aware that the mains input socket can be pulled out from the back of the monitor s case while it is still attached to the mains cable. This exposes the user to live terminals on the end of the mains cable presenting a risk of electric shock. 9. If the input socket comes out of the rear of the monitor or the mains cable appears to be disconnected, the mains cable should not be touched. Electrical power should be turned off at the wall outlet and the mains plug removed before examining the cause of the problem. If the input socket at the rear of the monitor has detached completely or partially from the casing, the monitor and cable should be removed from use immediately and sent for repair. On no account should an attempt be made to refit the input socket to the monitor. 10. The precautions given in the GE Medical Systems Important UK Product Hazard Notice should be followed (see Appendix 1). 11. All implicated monitors should be identified with reference to the attachment in Appendix 1. Users unsure of the modification status of their monitors should contact the service department in their own organisation or the manufacturer s Clinical Service Department at the address given under Enquiries. 12. Where required, the GE Clinical Service Department should be contacted to arrange for modification involving a field visit or an upgrade kit. These will be provided free of charge. REFERENCES 1) IRIC Website for safety warnings: NHSnet users only; follow Published Hazard and Safety Action Notices. This will reveal this Hazard Notice, the Manufacturer s Notice and attachment, and a photograph of live terminals. 2) MDA Website: follow: Publications, MDA Safety Warnings, Hazard Notices, Alternatively, type Dinamap into the search box. This will reveal the MDA Hazard Notice HN2002(04), the Manufacturer s Notice and attachment, and a photograph of live terminals. ENQUIRIES Enquiries to the manufacturer should be addressed to: Scott Hodgson, UK Operations Leader GE Medical Systems Information Technologies Service 2210 Kettering Parkway Kettering Tel: Northants Fax: NN15 6XR scott.hodgson@med.ge.com SCOTTISH HEALTHCARE SUPPLIES Gyle Square Edinburgh EH12 9EB A Division of the National Service Scotland for NHSScotland CONTACT iric@shs.csa.scot.nhs.uk FAX: WEBSITE: N:\WORD\HAZ\PUBLIC LIBRARY HAZ\2002 HAZ\PHAZ0204.DOC

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