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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
2020 29 31
2021 79 79
2022 50 50
2023 1248 1248
2024 557 558
2025 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1029 1029
Wireless Communication Problem 902 903
Appropriate Term/Code Not Available 112 112
No Display/Image 74 74
Problem with Software Installation 49 49
Output Problem 36 36
Data Problem 28 28
Application Program Problem 15 15
Communication or Transmission Problem 14 14
Image Display Error/Artifact 13 13
Connection Problem 12 12
Poor Quality Image 12 12
Patient Data Problem 11 13
Application Program Problem: Medication Error 8 8
Device Markings/Labelling Problem 5 5
Application Network Problem 5 5
Application Program Problem: Dose Calculation Error 5 5
Battery Problem 4 4
Display or Visual Feedback Problem 4 4
Product Quality Problem 4 4
Degraded 4 4
Date/Time-Related Software Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Material Integrity Problem 3 3
Inadequate User Interface 3 3
Unexpected Shutdown 3 3
Device Alarm System 3 3
Improper or Incorrect Procedure or Method 3 3
Overheating of Device 3 3
Protective Measures Problem 3 3
Sparking 3 3
Intermittent Loss of Power 3 3
Nonstandard Device 2 2
Optical Problem 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Fire 2 2
Calibration Problem 2 2
Human-Device Interface Problem 2 2
Temperature Problem 2 2
Unintended Electrical Shock 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Delayed Program or Algorithm Execution 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
No Apparent Adverse Event 1 1
Unintended Application Program Shut Down 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fail-Safe Did Not Operate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1932 1935
Insufficient Information 61 61
No Known Impact Or Consequence To Patient 13 13
Hyperglycemia 4 4
Hypoglycemia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Headache 2 2
Cough 2 2
Itching Sensation 1 1
Myocardial Infarction 1 1
Pain 1 1
Rash 1 1
Tinnitus 1 1
Blurred Vision 1 1
Visual Disturbances 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Arrhythmia 1 1
Asthma 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Hypoglycemic Shock 1 1
Patient Problem/Medical Problem 1 1
Taste Disorder 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Respiratory Problem 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Anaphylactoid 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Distress 1 1
Diabetic Ketoacidosis 1 1
Respiratory Tract Infection 1 1
Nasal Obstruction 1 1
Burn, Thermal 1 1
Confusion/ Disorientation 1 1
Electric Shock 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 Pentax of America Inc II Oct-23-2020
5 Radiometer Medical ApS II Apr-17-2023
6 Radiometer Medical ApS II Jan-24-2020
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