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U.S. Department of Health and Human Services

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 CodeOUG
Regulation Number 880.6310
Device Class 1

MDR Year MDR Reports MDR Events
2017 16 16
2018 414 414
2019 45 45
2020 29 31
2021 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 427 427
Data Problem 34 34
No Display/Image 30 30
Output Problem 16 16
Patient Data Problem 12 14
Application Program Problem 10 10
Image Display Error/Artifact 8 8
Communication or Transmission Problem 6 6
Application Program Problem: Dose Calculation Error 6 6
Application Program Problem: Medication Error 6 6
Device Markings/Labelling Problem 5 5
Product Quality Problem 5 5
Display or Visual Feedback Problem 4 4
Poor Quality Image 4 4
Use of Device Problem 4 4
Device Operates Differently Than Expected 4 4
Problem with Software Installation 4 4
Protective Measures Problem 3 3
Overheating of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Incorrect Measurement 3 3
Computer Operating System Problem 3 3
Connection Problem 3 3
Loss of Data 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Sparking 2 2
Entrapment of Device 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Inadequate User Interface 2 2
Compatibility Problem 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Problem 1 1
Electrical Shorting 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Missing Test Results 1 1
Noise, Audible 1 1
Non Reproducible Results 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unintended Application Program Shut Down 1 1
Intermittent Communication Failure 1 1
Pacing Problem 1 1
Device Difficult to Setup or Prepare 1 1
False Negative Result 1 1
Fire 1 1
Electrical /Electronic Property Problem 1 1
Defective Alarm 1 1
Break 1 1
Detachment Of Device Component 1 1
Radio Signal Problem 1 1
Failure to Transmit Record 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Smoking 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Patient-Device Incompatibility 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
No Device Output 1 1
Failure to Calibrate 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 397 397
No Known Impact Or Consequence To Patient 72 72
No Clinical Signs, Symptoms or Conditions 70 72
Insufficient Information 38 38
No Consequences Or Impact To Patient 7 7
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Underdose 2 2
Electric Shock 2 2
Anaphylactoid 1 1
Toxicity 1 1
Burn, Thermal 1 1
Death 1 1
Fall 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoglycemia 1 1
Overdose 1 1
Swelling 1 1
Dizziness 1 1
Cough 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-06-2020
2 BioMerieux SA II Oct-08-2021
3 ENDOTRONIX II Nov-22-2019
4 Intel-GE Care Innovations LLC II Jul-16-2018
5 Medtronic MiniMed Inc. II Oct-11-2018
6 Merge Healthcare, Inc. II Mar-20-2017
7 Opternative Inc II Aug-08-2019
8 Pentax of America Inc II Oct-23-2020
9 Philips Electronics North America Corporation II Jan-26-2017
10 Radiometer Medical ApS II Jan-24-2020
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