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Health Sciences Authority
Dear Healthcare Professional Letters

Field Safety Notice regarding all HeartWare® Ventricular Assist System batteries

Audiences

Healthcare professional

Product type

Medical devices

6 June 2014

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

HeartWare Inc. (HeartWare) would like to inform healthcare professionals of a corrective action of the HeartWare® Ventricular Assist System batteries. HeartWare has identified an increase in reported HeartWare® System power management complaints related to both premature battery failure and routine battery handling. Premature or unrecognized deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. Healthcare professionals are advised to perform verification checks on their patients implanted with the HeartWare® Ventricular Assist System, to follow the recommended practices in the DHCPL, and to educate patients on proper management of power sources. Healthcare professionals are advised to 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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