Advanced, yet easy to use, the PageWriter TC30 offers speed of operation in an attractive and affordable solution that can grow with you as your workflow evolves. Price above includes required Digital PIM 12 Lead (Philips option code H21). Population Healthcare Division, Welsh GovernmentĮmail: report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).Philips PageWriter TC30 Cardiograph Machine - item #860306, item #EK860306 Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services ScotlandĮmail: report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.įor more information, or if you can't access the webform, visit the website: how to report an adverse incident Wales Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health, Social Services and Public SafetyĮmail: report an adverse incident involving a medical device in Northern Ireland use the forms on the website.Īlerts in Northern Ireland are distributed via the NICAS system.
Technical aspectsĮmail: report an adverse incident involving a medical device in England use the Yellow Card reporting page Northern Ireland Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: and requesting this facility. Please note: CQC and OFSTED do not distribute these alerts. Care homes providing nursing care (adults).Intensive care nursing staff (paediatric)Įstablishments registered with the Care Quality Commission (CQC) (England only).Intensive care medical staff/paediatrics.If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.ĬAS and NICAS liaison officers for onward distribution to all relevant staff including: If you have these devices, please ensure that the actions described in that MDA have been completed. However, the existing labelling does not include full instructions on how to use this information to determine when to replace the battery.Ī previous medical device alert MDA/2018/0031 was published for the same issue in Philips Suresigns VS and VM patient monitors and viewing stations manufactured before the. The device can display actual information on the battery state of health and charge-discharge cycles. Philips have received reports of lithium ion batteries overheating and igniting when they exceed 300 charge/discharge cycles or when battery capacity fell below 80% that of a new battery. Do not wait for a communication from MHRA. Remember if your organisation receives an FSN from a manufacturer, always act on it. Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). You should also report directly to manufacturers if your local or national systems do not.Īll medical, nursing and technical staff involved in the use and maintenance of these devices. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.Contact Philips to order replacement batteries. Once installed, the device will indicate via an error message if battery replacement is necessary.Install the software update (version A.01.11) described in the F SN.Philips are developing a software update that will assist in battery management and will contact you once this is available. Ensure that systems are in place to routinely assess battery condition.
If necessary, replace the battery in accordance with the instructions in the FSN. Check if the battery has exceeded 300 charge-discharge cycles or if the battery state of health is less than 80%.Identify all affected devices using the manufacturer's Field Safety Notices (FSNs) for the TC Cardiograph and the Efficia monitor.Ĭontact Philips to confirm receipt of each FSN using their response form. Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
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