![]() 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.
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