TPLC - Total Product Life Cycle

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Device	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	1037	1037
Wireless Communication Problem	819	819
Appropriate Term/Code Not Available	107	107
No Display/Image	68	68
Problem with Software Installation	47	47
Output Problem	36	36
Data Problem	32	32
Application Program Problem	17	17
Communication or Transmission Problem	15	15
Image Display Error/Artifact	13	13
Poor Quality Image	13	13
Patient Data Problem	12	14
Application Program Problem: Medication Error	11	11
Connection Problem	9	9
Product Quality Problem	6	6
Application Program Problem: Dose Calculation Error	6	6
Inadequate User Interface	5	5
Application Network Problem	5	5
Device Markings/Labelling Problem	5	5
Use of Device Problem	5	5
Display or Visual Feedback Problem	4	4
Battery Problem	4	4
Intermittent Loss of Power	3	3
Improper or Incorrect Procedure or Method	3	3
Overheating of Device	3	3
Human-Device Interface Problem	3	3
Protective Measures Problem	3	3
Date/Time-Related Software Problem	3	3
Degraded	3	3
Sparking	3	3
Material Integrity Problem	3	3
Unexpected Shutdown	3	3
Device Alarm System	3	3
Temperature Problem	2	2
Inadequate Instructions for Non-Healthcare Professional	2	2
Defective Device	2	2
Delayed Program or Algorithm Execution	2	2
Entrapment of Device	2	2
Fire	2	2
Patient-Device Incompatibility	2	2
Calibration Problem	2	2
Nonstandard Device	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Unintended Electrical Shock	2	2
Noise, Audible	1	1
No Device Output	1	1
Device Slipped	1	1
Activation, Positioning or Separation Problem	1	1
Compatibility Problem	1	1
Incorrect Interpretation of Signal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1829	1831
Insufficient Information	60	60
No Known Impact Or Consequence To Patient	50	50
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hyperglycemia	3	3
Hypoglycemia	3	3
Patient Problem/Medical Problem	2	2
No Code Available	2	2
Cough	2	2
Headache	2	2
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
Overdose	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
No Patient Involvement	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
Tinnitus	1	1
Distress	1	1