TPLC - Total Product Life Cycle

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Device	calculator, drug dose
Regulation Description	Predictive pulmonary-function value calculator.
Product Code	NDC
Regulation Number	868.1890
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMALGAM RX, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
GLOOKO, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K260910 EndoTool IV Cloud 1.0
GLYTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1
GNC HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC MINIMED
	SUBSTANTIALLY EQUIVALENT	2
MONARCH MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MONARCH MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
UPDOC, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLUNTIS SA.
	SUBSTANTIALLY EQUIVALENT	2
WELLDOC, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	984	985
Computer Software Problem	424	425
Appropriate Term/Code Not Available	60	61
Adverse Event Without Identified Device or Use Problem	37	37
Break	27	27
Data Problem	24	24
Patient Device Interaction Problem	20	20
Battery Problem	18	18
Insufficient Flow or Under Infusion	16	16
Material Integrity Problem	11	11
Obstruction of Flow	10	10
Key or Button Unresponsive/not Working	10	10
Power Problem	6	6
Communication or Transmission Problem	6	7
Mechanical Problem	5	5
Unauthorized Access to Computer System	5	5
Application Program Problem: Dose Calculation Error	4	4
Material Too Rigid or Stiff	4	4
Device Alarm System	4	4
No Display/Image	4	4
Failure to Align	3	3
Application Program Problem	3	3
No Apparent Adverse Event	3	3
Priming Problem	3	3
Fluid/Blood Leak	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Circuit Failure	2	2
Grounding Malfunction	2	2
Connection Problem	2	2
Problem with Software Installation	1	1
Use of Device Problem	1	1
Insufficient Information	1	1
Application Program Version or Upgrade Problem	1	1
Excess Flow or Over-Infusion	1	1
Infusion or Flow Problem	1	1
Moisture or Humidity Problem	1	1
Device Sensing Problem	1	2
Inaccurate Delivery	1	2
Fracture	1	1
Inadequate or Insufficient Training	1	1
Application Network Problem	1	1
Human-Device Interface Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Loss of Data	1	1
Intermittent Loss of Power	1	1
Intermittent Communication Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1454	1456
Hyperglycemia	61	61
Hypoglycemia	23	24
Insufficient Information	11	12
Diabetic Ketoacidosis	2	2
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dehydration	1	1
Dyspnea	1	1
Pneumonia	1	1
Ulcer	1	1
Loss of consciousness	1	1