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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
2019 45 45
2020 29 31
2021 79 79
2022 50 50
2023 1248 1248
2024 280 280

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 940 940
Wireless Communication Problem 703 703
Appropriate Term/Code Not Available 82 82
No Display/Image 61 61
Problem with Software Installation 45 45
Output Problem 35 35
Data Problem 32 32
Application Program Problem 17 17
Communication or Transmission Problem 15 15
Poor Quality Image 13 13
Image Display Error/Artifact 11 11
Patient Data Problem 11 13
Application Program Problem: Medication Error 11 11
Application Program Problem: Dose Calculation Error 6 6
Product Quality Problem 6 6
Use of Device Problem 5 5
Application Network Problem 5 5
Connection Problem 5 5
Device Markings/Labelling Problem 5 5
Inadequate User Interface 5 5
Battery Problem 4 4
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
Material Integrity Problem 3 3
Human-Device Interface Problem 3 3
Intermittent Loss of Power 3 3
Unexpected Shutdown 3 3
Protective Measures Problem 3 3
Temperature Problem 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Patient-Device Incompatibility 2 2
Calibration Problem 2 2
Defective Device 2 2
Overheating of Device 2 2
Degraded 2 2
Device Alarm System 2 2
Entrapment of Device 2 2
Nonstandard Device 2 2
Delayed Program or Algorithm Execution 2 2
Fail-Safe Did Not Operate 1 1
No Device Output 1 1
Incorrect Measurement 1 1
False Negative Result 1 1
Fire 1 1
Break 1 1
Use of Incorrect Control/Treatment Settings 1 1
Erratic or Intermittent Display 1 1
Device Difficult to Setup or Prepare 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, Inadequate or Imprecise Result or Readings 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
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Computer Operating System Problem 1 1
Electrical Shorting 1 1
Fail-Safe Problem 1 1
Optical Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Application Program Shut Down 1 1
Program or Algorithm Execution Problem 1 1
Non Reproducible Results 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Missing Test Results 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1622 1624
Insufficient Information 58 58
No Known Impact Or Consequence To Patient 50 50
No Consequences Or Impact To Patient 4 4
Hyperglycemia 3 3
Hypoglycemia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Headache 2 2
Cough 2 2
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Arrhythmia 1 1
Taste Disorder 1 1
Itching Sensation 1 1
Myocardial Infarction 1 1
Overdose 1 1
Pain 1 1
Rash 1 1
Tinnitus 1 1
Blurred Vision 1 1
Visual Disturbances 1 1
Dizziness 1 1
Anaphylactoid 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Distress 1 1
Nasal Obstruction 1 1
Burn, Thermal 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
No Patient Involvement 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 Opternative Inc II Aug-08-2019
6 Pentax of America Inc II Oct-23-2020
7 Radiometer Medical ApS II Apr-17-2023
8 Radiometer Medical ApS II Jan-24-2020
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