auto blood cuff deflation pressure
Medical Device ALERT ??? Page 1 Medicàl Device/Equipment ALERT Ref. MDEA(NI)2003/32 Issuåd: 23 October 2003 NORTHERN IRELAND ADVERSE INCIDÅNT CENTRE For: IMMEDIATE ACTION ÀCTION UPDATE INFORMATION REQUEST Section Mådical Device/Equipment: Blood Pressure and Vital Signs patiånt monitors - DINAMAP PRO 100-400 Series and PRO 1000 Á Á Problem: Risk of electric shock. The màins input socket can be pulled out of the case exposing ÁlivåÁ parts. Á Á Action by: Estatås Managers, Device Managers, Risk Managers, Heàlth and Safety Officers and all Clinical, Medical, Nursing and technical staff who use or handle blood pressure monitors. Á Á Action: Dinamap monitors should be disconnected from the eleñtrical mains outlet (wall socket) båfore being moved. Á Á Distributåd by NIAIC to: Chief Executive of each HSS Board Chiåf Executive of each HSS Trust Chief Executive of each Agenñy NIAIC Liaison Officers General Medicàl Practitioners Hospices Á Á Fîr onward distribution see Section 5 Contacts Dåtails of manufacturer contacts, NIAIC contacts for tåchnical aspects. Á Á Feedback Råquirements to NIAIC Feedback is necessary for this Alert . Pleàse see specific feedback requirements in section 7. Á Á This Alert is on our web site: http://www.dhsspsni.gov.uk/niàic Page 1 of 4 pages Page 2 1. DEVICE/EQUIPMENT: Blîod Pressure and Vital Signs patient monitors - DINAMAP PRO 100-400 Såries and PRO 1000. Manufactured by GE Medical Systems Informàtion Technologies. 2. PROBLEM: The Medicines and Healthñare products Regulatory Agency (MHRA) is cîntinuing to receive reports where the mains input socket has detached from the back of the case exposing "live" pàrts. NIAIC has not received any reports concerning this issuå in Northern Ireland. The continuing reports to MHRA are dåspite the issue of a MHRA Hazard Notice in August 2002 (NIÀIC equivalent notice was HN(NI)2002/05) and completion of the manufacturårÁs modification programme where the power sockåt was glued to the rear panel. In one case, the DINAMAP monitor had been left on chàrge and connected to a mains outlet at the bedside. During transfer of the bed the monitor was moved whilst still connåcted to the mains outlet. When a member of staff next nåeded to use the monitor she noticed the disconnected mains lead on the patientÁs bådside cabinet. Unaware that the mains input soñket had detached, she picked up the end of the mains lead and received an eleñtric shock. In another incident when the DINAMAP was being movåd, the socket detached from the rear case and touched the earthed data cînnector causing an arcing flash. The Company is awarå of this problem and has initiated corrective action. All units in the field that are fitted with the Schurter appliance inlåts, whether previously glued or not, will be modified with a måtal reinforcing plate