TPLC - Total Product Life Cycle

show TPLC since

Device	outpatient cardiac telemetry
Regulation Description	Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Definition	Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.
Product Code	QYX
Regulation Number	870.1025
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Transmit Record	403	403
Adverse Event Without Identified Device or Use Problem	11	11
Patient-Device Incompatibility	7	7
Use of Device Problem	3	3
Inaccurate Information	3	3
Patient Data Problem	2	2
Insufficient Information	1	1
Unclear Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Heart Problem	411	411
Insufficient Information	9	9
Skin Inflammation/ Irritation	3	3
Skin Infection	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Syncope/Fainting	1	1
Itching Sensation	1	1
Anaphylactoid	1	1
Cellulitis	1	1
Burn(s)	1	1
Chest Pain	1	1
Erythema	1	1
Pain	1	1
Scar Tissue	1	1
Contact Dermatitis	1	1
Caustic/Chemical Burns	1	1
Skin Burning Sensation	1	1