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	1254	1257
Computer Software Problem	1059	1059
Appropriate Device Problem Term/Code Not Available	115	115
No Display/Image	48	48
Problem with Software Installation	48	48
Data Problem	25	25
Output Problem	24	24
Communication or Transmission Problem	19	19
Image Display Error/Artifact	15	15
Connection Problem	13	13
Poor Quality Image	9	9
Device Alarm System	6	6
Degraded	6	6
Application Network Problem	5	5
Patient Data Problem	5	5
Unexpected Shutdown	3	3
Intermittent Loss of Power	3	3
Battery Problem	3	3
Date/Time-Related Software Problem	3	3
Temperature Problem	2	2
Display or Visual Feedback Problem	2	2
Overheating of Device	2	2
Electrical Shorting	2	2
Optical Problem	2	2
Calibration Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Excess Flow or Over-Infusion	2	2
Application Program Freezes or Fails to Launch	2	2
Contamination	2	2
Unintended Electrical Shock	2	2
Application Program Problem	2	2
Sparking	2	2
Missing Test Results	1	1
Program or Algorithm Execution Problem	1	1
Unintended Application Program Shut Down	1	1
Telemetry Discrepancy	1	1
Failure to Unfold or Unwrap	1	1
No Apparent Adverse Event	1	1
Smoking	1	1
Erratic or Intermittent Display	1	1
Failure to Calibrate	1	1
Human-Device Interface Problem	1	2
Incorrect Interpretation of Signal	1	1
Fire	1	1
False Negative Result	1	1
Break	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2288	2293
Insufficient Information	58	58
Hyperglycemia	12	12
Hypoglycemia	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	6
Electric Shock	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Pain	2	13
Elevated ketones/Diabetic Ketoacidosis	2	2
Cough	2	13
Headache	2	13
Arrhythmia	1	12
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
Bone Cement Implantation Syndrome	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