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Health Sciences Authority
Dear Healthcare Professional Letters

Hazard alert for HeartWare® Controller

Audiences

Healthcare professional

Product type

Medical devices

10 June 2016

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

HeartWare Inc (HeartWare) would like to notify healthcare professionals of the possibility of loose power and data connectors on Heartware® Controllers due to reports received during ongoing product performance monitoring. HeartWare® Controllers are manufactured to possess a certain level of protection from water exposure. If a power or data connector becomes loose, Controllers could become more vulnerable to water damage. Healthcare professionals are advised to remind patients supported by the HeartWare® Ventricular Assist System to follow all instructions in their Patient Manuals, and inspect Controllers for loose connectors during patients’ regularly scheduled appointments. 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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