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
GNC HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC MINIMED
	SUBSTANTIALLY EQUIVALENT	2
MONARCH MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
1. K241088 EndoTool IV (3.1)
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	962	963
Computer Software Problem	421	422
Appropriate Term/Code Not Available	59	60
Adverse Event Without Identified Device or Use Problem	27	27
Break	24	24
Data Problem	24	24
Patient Device Interaction Problem	20	20
Battery Problem	14	14
Insufficient Flow or Under Infusion	13	13
Obstruction of Flow	10	10
Material Integrity Problem	9	9
Key or Button Unresponsive/not Working	8	8
Unauthorized Access to Computer System	5	5
Communication or Transmission Problem	4	5
Power Problem	4	4
Application Program Problem: Dose Calculation Error	4	4
Material Too Rigid or Stiff	4	4
Fluid/Blood Leak	3	3
Priming Problem	3	3
No Apparent Adverse Event	3	3
Failure to Align	3	3
Application Program Problem	3	3
Device Alarm System	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Grounding Malfunction	2	2
Connection Problem	2	2
No Display/Image	2	2
Circuit Failure	2	2
Use of Device Problem	1	1
Problem with Software Installation	1	1
Insufficient Information	1	1
Excess Flow or Over-Infusion	1	1
Infusion or Flow Problem	1	1
Moisture or Humidity Problem	1	1
Application Program Version or Upgrade Problem	1	1
Device Sensing Problem	1	2
Inaccurate Delivery	1	2
Mechanical Problem	1	1
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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1419	1421
Hyperglycemia	46	46
Hypoglycemia	20	21
Insufficient Information	11	12
Diabetic Ketoacidosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dehydration	1	1
Dyspnea	1	1
Ulcer	1	1
Loss of consciousness	1	1