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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
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
2018 414 414
2019 45 45
2020 29 31
2021 79 79
2022 50 50
2023 449 449

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 654 654
Wireless Communication Problem 226 226
No Display/Image 49 49
Output Problem 35 35
Data Problem 35 35
Problem with Software Installation 22 22
Appropriate Term/Code Not Available 22 22
Application Program Problem 16 16
Communication or Transmission Problem 14 14
Poor Quality Image 13 13
Patient Data Problem 12 14
Application Program Problem: Medication Error 11 11
Image Display Error/Artifact 8 8
Application Program Problem: Dose Calculation Error 7 7
Device Markings/Labelling Problem 7 7
Connection Problem 6 6
Product Quality Problem 6 6
Use of Device Problem 5 5
Inadequate User Interface 5 5
Display or Visual Feedback Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Date/Time-Related Software Problem 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Material Integrity Problem 3 3
Protective Measures Problem 3 3
Temperature Problem 2 2
Insufficient Information 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Human-Device Interface Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Entrapment of Device 2 2
Nonstandard Device 2 2
Overheating of Device 2 2
Intermittent Loss of Power 2 2
Non Reproducible Results 1 1
Pacing Problem 1 1
Device Difficult to Setup or Prepare 1 1
No Device Output 1 1
False Negative Result 1 1
Fire 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Electrical /Electronic Property Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defective Alarm 1 1
Detachment Of Device Component 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Failure to Advance 1 1
Failure to Transmit Record 1 1
Incorrect Interpretation of Signal 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Smoking 1 1
Telemetry Discrepancy 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Operates Differently Than Expected 1 1
Electrical Shorting 1 1
Fail-Safe Problem 1 1
Battery Problem 1 1
Loss of Data 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Unintended Application Program Shut Down 1 1
Program or Algorithm Execution Problem 1 1
Delayed Program or Algorithm Execution 1 1
Intermittent Communication Failure 1 1
Fail-Safe Did Not Operate 1 1
Missing Test Results 1 1
Noise, Audible 1 1
No Flow 1 1
Optical Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 551 553
No Information 396 396
No Known Impact Or Consequence To Patient 62 62
Insufficient Information 56 56
No Consequences Or Impact To Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Cough 2 2
Electric Shock 2 2
Headache 2 2
Hyperglycemia 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoglycemia 1 1
Itching Sensation 1 1
Myocardial Infarction 1 1
Overdose 1 1
Pain 1 1
Rash 1 1
Swelling 1 1
Tinnitus 1 1
Blurred Vision 1 1
Visual Disturbances 1 1
Dizziness 1 1
No Patient Involvement 1 1
Arrhythmia 1 1
Death 1 1
Fall 1 1
Anaphylactoid 1 1
Distress 1 1
Burn, Thermal 1 1
Underdose 1 1
Confusion/ Disorientation 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Taste Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-06-2020
2 BioMerieux SA II Oct-08-2021
3 Biomerieux Inc II Mar-02-2023
4 ENDOTRONIX II Nov-22-2019
5 Intel-GE Care Innovations LLC II Jul-16-2018
6 Medtronic MiniMed Inc. II Oct-11-2018
7 Opternative Inc II Aug-08-2019
8 Pentax of America Inc II Oct-23-2020
9 Radiometer Medical ApS II Apr-17-2023
10 Radiometer Medical ApS II Jan-24-2020
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