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
Computer Software Problem	1029	1029
Wireless Communication Problem	929	930
Appropriate Term/Code Not Available	112	112
No Display/Image	76	76
Problem with Software Installation	49	49
Output Problem	37	37
Data Problem	30	30
Image Display Error/Artifact	15	15
Application Program Problem	15	15
Communication or Transmission Problem	14	14
Connection Problem	14	14
Poor Quality Image	12	12
Patient Data Problem	11	13
Application Program Problem: Medication Error	8	8
Application Program Problem: Dose Calculation Error	5	5
Device Markings/Labelling Problem	5	5
Application Network Problem	5	5
Product Quality Problem	4	4
Battery Problem	4	4
Degraded	4	4
Display or Visual Feedback Problem	4	4
Protective Measures Problem	3	3
Date/Time-Related Software Problem	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Overheating of Device	3	3
Material Integrity Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Intermittent Loss of Power	3	3
Device Alarm System	3	3
Inadequate User Interface	3	3
Unexpected Shutdown	3	3
Sparking	3	3
Delayed Program or Algorithm Execution	2	2
Defective Device	2	2
Human-Device Interface Problem	2	2
Patient-Device Incompatibility	2	2
Unintended Electrical Shock	2	2
Nonstandard Device	2	2
Use of Device Problem	2	2
Temperature Problem	2	2
Excess Flow or Over-Infusion	2	2
Fire	2	2
Calibration Problem	2	2
Optical Problem	2	2
Inadequate Instructions for Non-Healthcare Professional	2	2
Incorrect Interpretation of Signal	1	1
Failure to Calibrate	1	1
Inaccurate Delivery	1	1
Erratic or Intermittent Display	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1962	1965
Insufficient Information	62	62
No Known Impact Or Consequence To Patient	13	13
Hyperglycemia	4	4
Hypoglycemia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Diabetic Ketoacidosis	2	2
Cough	2	2
Headache	2	2
Patient Problem/Medical Problem	1	1
Arrhythmia	1	1
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	1
Asthma	1	1
Itching Sensation	1	1
Anaphylactoid	1	1
Burn, Thermal	1	1
Skin Disorders	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Confusion/ Disorientation	1	1
Rash	1	1
Visual Disturbances	1	1
Respiratory Tract Infection	1	1
Pain	1	1
Nasal Obstruction	1	1
Heart Failure/Congestive Heart Failure	1	1
Hypoglycemic Shock	1	1
Myocardial Infarction	1	1
Blurred Vision	1	1
Unspecified Respiratory Problem	1	1
Tinnitus	1	1
No Consequences Or Impact To Patient	1	1
Distress	1	1