TPLC - Total Product Life Cycle

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Device	medical device data system
Regulation Description	Medical device data system.
Definition	A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
Product Code	OUG
Regulation Number	880.6310
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	1243	1245
Computer Software Problem	1052	1052
Appropriate Term/Code Not Available	114	114
No Display/Image	66	66
Problem with Software Installation	50	51
Data Problem	34	46
Output Problem	31	33
Communication or Transmission Problem	16	17
Image Display Error/Artifact	15	15
Connection Problem	13	13
Application Program Problem	12	13
Poor Quality Image	10	10
Patient Data Problem	8	8
Application Program Problem: Medication Error	8	10
Degraded	6	6
Device Markings/Labelling Problem	5	5
Application Network Problem	5	5
Device Alarm System	4	4
Product Quality Problem	4	4
Sparking	3	3
Inadequate User Interface	3	3
Unexpected Shutdown	3	3
Intermittent Loss of Power	3	3
Improper or Incorrect Procedure or Method	3	3
Material Integrity Problem	3	3
Battery Problem	3	3
Date/Time-Related Software Problem	3	3
Application Program Problem: Dose Calculation Error	3	3
Temperature Problem	2	2
Display or Visual Feedback Problem	2	2
Overheating of Device	2	2
Human-Device Interface Problem	2	3
Nonstandard Device	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Protective Measures Problem	2	2
Optical Problem	2	2
Calibration Problem	2	2
Excess Flow or Over-Infusion	2	2
Contamination	2	2
Defective Device	2	3
Patient-Device Incompatibility	2	13
Unintended Electrical Shock	2	2
Fire	2	2
Adverse Event Without Identified Device or Use Problem	1	1
Missing Test Results	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Device Difficult to Setup or Prepare	1	1
Program or Algorithm Execution Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2257	2262
Insufficient Information	58	58
Hyperglycemia	13	13
Hypoglycemia	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	6
Diabetic Ketoacidosis	2	2
Pain	2	13
Cough	2	13
Headache	2	13
Hemorrhage/Bleeding	2	2
Arrhythmia	1	12
Electric Shock	1	1
Pancreatitis	1	1
Gastrointestinal Hemorrhage	1	1
Dizziness	1	1
Rectal Anastomotic Leakage	1	1
Skin Inflammation/ Irritation	1	1
Taste Disorder	1	12
Itching Sensation	1	12
Skin Disorders	1	12
Asthma	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Confusion/ Disorientation	1	1
Rash	1	12
Visual Disturbances	1	12
Discomfort	1	1
Respiratory Tract Infection	1	1
Dyspnea	1	1
Paresis	1	1
Nasal Obstruction	1	1
Heart Failure/Congestive Heart Failure	1	1
Hypoglycemic Shock	1	1
Blurred Vision	1	12
Myocardial Infarction	1	1
Unspecified Respiratory Problem	1	1
Tinnitus	1	12
Cancer	1	1
Distress	1	1