Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care.
Below are the MDAs we have published that are of particular relevance to anaesthetists. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Recent Medical Device Alerts relating to cardiology
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08 May 2012 | Medical Device Alert: Alaris® IVAC® 590 series blood set manufactured by CareFusion (MDA/2012/023)
This Medical Device Alert has been issued as the MHRA has been informed that the manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set when using Alaris® IVAC® 590 series blood sets.
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16 Mar 2012 | Medical Device Alert: Implantable cardioverter defibrillators (ICD) manufactured by Medtronic (MDA/2012/014)
This Medical Device Alert has bee issued due to the risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately two and a half years after implantation.
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15 Mar 2012 | Medical Device Alert: Patient vital signs monitor manufactured by Philips Healthcare (MDA/2012/012)
This Medical Device Alert has been issued as patient vital signs monitors may not visually or audibly alarm to alert users at the central station.
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22 Dec 2011 | Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical (MDA/2011/112)
This Medical Device Alert has been issued as there is a risk of inappropriate therapy due to wear and/or abrasion of lead insulation after implantation when using Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.
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15 Jun 2011 | Medical Device Alert: Needle-free intravenous connectors. All manufacturers (MDA/2011/068)
This Medical Device Alert has been issued due an incompatibility of some pre-filled glass syringes with various needle-free connectors and a possible risk of infection and/or air embolus to patients when an adaptor remains attached to a needle-free connector after use.
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13 Jun 2011 | Medical Device Alert: Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. Manufactured by Cameron Health (MDA/2011/067)
This Medical Device Alert has been issued as there is a risk of premature battery depletion.
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07 Jun 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)
This Medical Device Alert has been issued because the manufacturers published Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information.
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07 Jun 2011 | Medical Device Alert: Automatic external defibrillators (AEDs). Manufactured by Defibtech (MDA/2011/064)
This Medical Device Alert has been issued because the manufacturer published a Field Safety Notice (FSN) for this device on 11 March 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
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06 Jun 2011 | Medical Device Alert: Power supply for TruSat Pulse Oximeter. Manufactured by GE Healthcare (MDA/2011/061)
This Medical Device Alert has been issued as the plastic cases of the external power supply for GE TruSat pulse oximeters may break, exposing live parts, or may overheat and deform, presenting a risk of electric shock or burns to users.
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02 Jun 2011 | Medical Device Alert: Dual Chamber Pacemakers. Manufactured by Medtronic Ltd (MDA/2011/060)
This Medical Device Alert has been issued because the manufacturer published a Field Safety Notice (FSN) – Medtronic Reference: FA507 – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.
