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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cabinet, table and tray, anesthesia
Regulation Description Anesthetic cabinet, table, or tray.
Product CodeBRY
Regulation Number 868.6100
Device Class 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 57 57
2022 196 196
2023 314 314
2024 1600 1600
2025 6400 6400

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4078 4078
Computer Software Problem 2309 2309
Electrical /Electronic Property Problem 414 414
Communication or Transmission Problem 276 276
Failure to Eject 189 189
Power Problem 114 114
Smoking 96 96
Mechanical Jam 92 92
Unexpected Shutdown 81 81
Application Program Freezes, Becomes Nonfunctional 75 75
Application Network Problem 64 64
Temperature Problem 60 60
Date/Time-Related Software Problem 53 53
Appropriate Term/Code Not Available 51 51
Application Program Problem 50 50
Failure to Power Up 48 48
Connection Problem 47 47
Display or Visual Feedback Problem 46 46
Inadequate or Insufficient Training 30 30
Unintended Application Program Shut Down 30 30
Human-Device Interface Problem 25 25
Labelling, Instructions for Use or Training Problem 23 23
Difficult to Open or Close 22 22
Computer Operating System Problem 20 20
Loose or Intermittent Connection 19 19
No Display/Image 18 18
Thermal Decomposition of Device 17 17
Defective Component 17 17
Sparking 15 15
Key or Button Unresponsive/not Working 15 15
Inadequate User Interface 14 14
Data Problem 10 10
Installation-Related Problem 10 10
Loss of Data 9 9
Insufficient Information 9 9
Battery Problem 9 9
Complete Loss of Power 9 9
Use of Device Problem 8 8
Patient Data Problem 8 8
Problem with Software Installation 7 7
Operating System Version or Upgrade Problem 7 7
Fire 7 7
Intermittent Loss of Power 7 7
Failure to Shut Off 7 7
Overheating of Device 6 6
Flare or Flash 6 6
Break 6 6
Ejection Problem 5 5
Failure to Sense 5 5
Computer System Security Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8332 8332
Insufficient Information 217 217
No Patient Involvement 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Discomfort 4 4
Pain 4 4
Atrial Fibrillation 3 3
Cardiac Arrest 3 3
Laceration(s) 3 3
Convulsion/Seizure 3 3
Unspecified Kidney or Urinary Problem 2 2
Anxiety 2 2
High Blood Pressure/ Hypertension 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Nausea 1 1
Respiratory Arrest 1 1
No Information 1 1
Thrombosis/Thrombus 1 1
Eye Injury 1 1
Hypoglycemia 1 1
Myocardial Infarction 1 1
Cardiovascular Insufficiency 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Decreased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Mar-17-2025
2 CareFusion 303, Inc. II Feb-21-2025
3 CareFusion 303, Inc. II Feb-21-2025
4 CareFusion 303, Inc. II Feb-21-2025
5 CareFusion 303, Inc. II Feb-11-2025
6 CareFusion 303, Inc. II Feb-07-2025
7 CareFusion 303, Inc. II Feb-07-2025
8 CareFusion 303, Inc. II Jan-30-2025
9 CareFusion 303, Inc. II Jan-17-2025
10 CareFusion 303, Inc. II Jan-14-2025
11 CareFusion 303, Inc. II Dec-11-2024
12 CareFusion 303, Inc. II Aug-30-2024
13 CareFusion 303, Inc. II Aug-20-2024
14 CareFusion 303, Inc. II Aug-02-2024
15 CareFusion 303, Inc. II Jul-17-2024
16 CareFusion 303, Inc. II Jul-02-2024
17 CareFusion 303, Inc. II May-30-2024
18 CareFusion 303, Inc. II Oct-10-2023
19 CareFusion 303, Inc. II Sep-28-2023
20 CareFusion 303, Inc. II Jul-05-2023
21 CareFusion 303, Inc. II May-11-2023
22 CareFusion 303, Inc. II Mar-17-2023
23 CareFusion 303, Inc. II Jan-10-2023
24 CareFusion 303, Inc. II Sep-23-2022
25 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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