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Health Sciences Authority
Dear Healthcare Professional Letters

Potential damage to Medtronic HeartWare Monitor AC Adapter under electric current surge conditions

Audiences

Healthcare professional

Product type

Medical devices

31 May 2019

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by HeartWare to inform healthcare professionals that the HeartWare Monitor AC (MAC) adapter may be damaged while connecting to an electrical outlet that is 220V AC or greater. All serial numbers of the MAC adapter are affected by the issue. If this damage occurs, the MAC adapter will no longer supply power to the monitor nor recharge the internal monitor battery. This damage does not impact the HeartWare controller, and no components of the HeartWare system are at risk of losing power due to the MAC adapter issue. A new MAC adaptor design change from Medtronic will accommodate electric current surge conditions that previously could damage the MAC adaptor. Of the currently distributed MAC adapters susceptible to this issue, Medtronic has a reported complaint rate of 14.6%. Healthcare professionals are advised to continue to use the HeartWare Monitor MAC adapter and associated HeartWare monitor per normal clinic activities, and to ensure that the monitor is functioning and the internal battery is fully charged prior to use. They are also advised to maintain the monitor’s connection to an electrical outlet at all times to minimize connection/disconnection cycles from the outlet to prevent occurrence of electric current surges through the power supply. If the MAC adapter is not functioning, they are requested to use an alternate monitor or MAC adapter if available and to follow standard complaint reporting process to receive a replacement MAC adapter by contacting their local Medtronic HeartWare Representative. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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