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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device remote or wearable patient monitoring device for drug induced qt prolongation monitoring
Definition To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency.
Product CodeQNY
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2